Management of Prediabetes

8/10/2019 Management of Prediabetes

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Management of Prediabetes

Treatment Goals

Despite the clear origins of diabetes-related complications observable early in the

prediabetic state, few recommendations exist for the identification and management of

patients with prediabetes.1 The goals of early (prediabetic) glucose-directed therapies

are to normalize glucose levels, prevent or delay progression to diabetes, prevent

microvascular complications, and modify other risk factors such as obesity,

hypertension, and dyslipidemia.

Therapeutic Lifestyle Management

Given its safety and the strength of evidence for its effectiveness in improving glycemia

and reducing CVD risk factors, the preferred treatment approach for prediabetes is

intensive lifestyle management.1

Therapeutic lifestyle management must be discussedwith all patients with prediabetes at the time of diagnosis and throughout their lifetimes.

Therapeutic lifestyle management includes medical nutrition therapy (MNT; the reduction

and modification of caloric and saturated/hydrogenated fat intake to achieve weight loss

in individuals who are overweight or obese), appropriately prescribed physical activity,

avoidance of tobacco products, adequate quantity and quality of sleep, limited alcohol

consumption, and stress reduction.2

While lifestyle modifications may be difficult to maintain, the following strategies have

been shown to increase the likelihood of patient success:1

Patient self-monitoring

Realistic and stepwise goal setting

Stimulus control

Cognitive strategies

Social support

Appropriate reinforcement

Primary care providers (PCPs) often take on the responsibility of encouraging behavior

changes.3The Avoiding Diabetes Through Action Plan Targeting (ADAPT) trial has

developed a system that combines evidence-based interventions for behavioral changewith existing health record technology to improve primary care providers ability to

effectively counsel patients on lifestyle behavior changes. The ADAPT system combines

shared goal setting and feedback, patient contracts, tailored approaches, reminders, and

other strategies to integrate evidence-based behavior change principles into the

electronic health record to optimize PCP counseling efficacy during routine visits. The

ADAPT system has the potential to be an adaptable and scalable technology-enabled

behavior change tool for PCPs.3

The effectiveness of structured lifestyle interventions was demonstrated in the US

Diabetes Prevention Program (DPP) clinical trial. The structured lifestyle interventions

included training people with prediabetes to achieve modest weight loss through diet and

physical activity. The DPP demonstrated a 3-year reduction in diabetes incidence by


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58%.4Continued benefit of lifestyle intervention was confirmed on a 10-year follow-up of

the DPP.5

A systematic meta-analysis and review of 28 US-based studies demonstrated that the

translation of the lifestyle interventions of the DPP into real-world settings gives

significant and sustainable benefits for people at high risk for diabetes.4This reviewfound an average weight loss of 4% from baseline at 12 months after the intervention.

Similar weight change was also shown in an additional analyses limited to 17 studies

with a 9-month or greater follow-up assessment. A 0.26 percentage point increase in

weight loss was shown with every additional lifestyle session attended. These findings

greatly support the implementation of the DPP lifestyle interventions in the treatment of

prediabetes.4

Medical Nutritional Therapy (MNT)

MNT is an important aspect of therapeutic lifestyle management that should be

discussed with every patient with prediabetes. MNT requires a detailed discussion of

calories, grams, and other nutritional metrics, as well as intensive implementation of

dietary recommendations aimed at optimizing glycemic control and reducing the risk for

diabetic complications. Recommendations should be personalized and, if possible, patient

evaluation and teaching should be conducted by a registered dietitian (RD) or

knowledgeable physician. In areas underserved by RDs, physicians will need to take on

more responsibility during patient encounters for nutritional counseling and

reinforcement of healthful eating patterns.2

Key MNT recommendations include the following:2

Consistency in day-to-day carbohydrate intake

Limitation of sucrose-containing or high-glycemic index foods

Adequate protein intake

Weight management

Exercise

Physical Activity

Aerobic exercise and strength training improve cardiovascular disease (CVD) risk factors,

decrease the risk of falls and fractures, and improve functional capacity and well-being.Physical activity is also a key component in weight loss and maintenance and is

particularly important in weight maintenance.2A program of regular moderate-intensity

physical activity for 30 to 60 minutes daily, at least 5 days per week, is recommended.1

Key points to remember when counseling patients on exercise are:2

Patients must be evaluated initially for contraindications and/or limitations to increased

physical activity.

An exercise prescription should be developed for each patient based on his or her goals

and limitations.

Any new physical activity should be started slowly and built up gradually.


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Weight Loss

Weight loss is a fundamental tenet of prediabetes management. Overweight individuals

with prediabetes should strive for a 5% to 10% reduction in weight and should avoid

weight gain. Both MNT and physical activity are essential to achieving this goal.1

Even a modest 5% to 10% degree of weight loss results in decreased fat mass, blood

pressure, glucose levels, and LDL cholesterol and triglyceride levels. These benefits can

translate into improved long-term outcomes, especially if weight loss and lifestyle

alterations are maintained.1

All patients should be advised on how to achieve and maintain a healthful weight,

corresponding to a normal BMI range between 18.5 and 24.9 kg/m2. Recommendations

should be personalized on the basis of a patients specific medical conditions, lifestyle,

and behaviors. Patients unable to maintain a healthy weight on their own should be

referred to an RD or weight-loss program with a proven history of success.2

Pharmacologic Approaches to Glucose Management in Prediabetes

For patients in whom lifestyle modification fails to produce necessary improvement after

3 to 6 months, pharmacologic intervention may be appropriate.2However, no

medications are currently approved by the FDA for the management of prediabetes;

thus, any decision to implement pharmacologic therapy for prediabetes, especially in

children/adolescents, is off-label and requires careful judgment regarding the risks and

benefits of each specific agent for each individual patient.1,6

A risk-benefit assessment should be conducted before starting any medication.Pharmacologic drug therapy should be considered for higher-risk patients rather than

lower-risk patients (unless there is evidence for progressive deterioration of blood

glucose levels despite lifestyle modification).1High-risk patients include those with some

combination of IFG, IGT, and/or themetabolic syndrome(ie, 2 of these risk factors).

Other key considerations in decision making should include worsening glycemia, the

presence of cardiovascular disease (CVD) and/or nonalcoholic fatty liver disease, or a

history of gestational diabetes mellitus (GDM) or polycystic ovary syndrome (PCOS).

There is strong evidence from randomized multicenter interventional trials that the drugs

metformin and acarbose reduce the progression of prediabetes to diabetes. While both

agents are less effective than intensive lifestyle management, they do have relatively

good safety profiles.1,2Similarly, thiazolidinediones (TZDs) have been shown to be

effective in delaying T2DM; however, their use in prediabetes is controversial due to

associated adverse effects. Finally, evidence exists to indicate that exenatide combined

with lifestyle changes can normalize glucose tolerance in high-risk patients. Further

study is warranted to investigate its role in the treatment of prediabetes.7

Metformin (class biguanide).Metformin is a biguanide that improves the ability of

insulin to suppress excess hepatic glucose production in both the fasting and

postprandial states. In the fasting state, metformin primarily decreases excessive

hepatic glucose production by decreasing gluconeogenesis and, to a lesser extent, bydecreasing glycogenolysis. In the postprandial state, insulin suppression of hepatic
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glucose production is enhanced. Thus, metformin is effective in decreasing both fasting

and postprandial glucose concentrations.8

Metformin has been shown to have beneficial effects on metabolic syndrome

components, including mild to moderate weight loss, lipid profile improvements, and

improved fibrinolysis.8 In addition, lifestyle and metformin are both highly effective indelaying or preventing T2DM in women with a history of GDM and IGT.9

In the DPP study, 3234 nondiabetic individuals with elevated fasting glucose and OGTT

values were randomly assigned to placebo, metformin (850 mg twice daily), or a

lifestyle-modification program with the goals of at least 150 minutes of physical activity

per week and at least a 7% weight loss.10In this study, lifestyle intervention reduced

T2DM incidence by 58% and metformin reduced it by 31% as compared with placebo.

Similar effects were observed in men and women and for all racial and ethnic groups.

The 3 original DPP study groups (intensive lifestyle; metformin 850 mg twice per day;

and placebo) were offered group-implemented lifestyle intervention for 10 years

following the initial study. In addition, the intensive lifestyle group was offered ongoing

lifestyle support. A 10-year follow-up of the DPP was published in 2009.5This found that

the long-term T2DM incidence rate in the lifestyle and metformin groups, respectively,

were reduced by 34% and 18% compared with placebo. The lifestyle effect was greatest

in participants aged 60 to 85 years at randomization (49% reduction); in this group,

metformin had no significant effect.

Acarbose (class alpha-glucosidase inhibitors).Acarbose, an alpha-glucosidase

inhibitor, works by delaying carbohydrate absorption from the intestine.11Acarbose has

been shown to improve CVD outcomes and reduce progression to diabetes in patientswith IGT.1,12,13

The impact of acarbose on CVD was investigated in patients with IGT in the STOP-

NIDDM trial, an international, multicenter, double-blind, placebo-controlled, randomized

trial undertaken from July 1998 through August 2001 in hospitals in Austria, Canada,

Denmark, Finland, Germany, Israel, Norway, Spain, and Sweden.12The STOP-NIDDM

trial included a total of 1368 patients with IGT who were followed up for a mean (SD) of

3.3 (1.2) years. In this trial, acarbose was associated with a significant reduction in the

incidence of both myocardial infarction and hypertension, suggesting a reduced risk of

CHD with this treatment.1,12,13Additionally, the relative risk of progression from IGT to

diabetes was reduced by 25% (as assessed by OGTT) in acarbose-treated patients vs

placebo-treated patients (HR 0.75, 95% CI 0.63-0.90, P=0.0015). This benefit held even

after adjusting for age, sex, and BMI.13

Pioglitazone or rosiglitazone (class thiazolidinediones [TZDs]).The

thiazolidinediones (TZDs) are effective in preventing T2DM in 62% to 72% of high-risk

patients. However, as mentioned previously, because of these drugs associated adverse

effects, their use in prediabetes is controversial.1,2TZDs increase peripheral insulin

sensitivity, with the benefit of increased HDL cholesterol and decreased

triglycerides.11Currently, pioglitazone is the only TZD available for use in the United

States (rosiglitazone may still be prescribed to selected patients).


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The Troglitazone in Prevention of Diabetes (TRIPOD) study showed that this TZD could

reduce the incidence of diabetes by more than 50% in Hispanic women with a history of

GDM. At the premature conclusion of the trial, annual diabetes incidence rates were

5.4% and 12.1% in the troglitazone and placebo groups, respectively. When evaluating

only women with IGT at baseline, the risk of progression to type T2DM was reduced by

49% with treatment (HR 0.51; 95% CI 0.28-0.95).14

The Pioglitazone in the Prevention of Diabetes (PIPOD) study is ongoing, and includes

women who finished the TRIPOD Study. The first-year study data show a similar

protective effect for pioglitazone against diabetes as was seen in TRIPOD.15

Exenatide (class glucagon-like peptide-1 [GLP-1] inhibitor).A 24-week study

evaluated exenatide in combination with lifestyle modification as treatment for weight

loss in nondiabetic obese subjects with NGT, IGT, or IFG. At baseline, 38 of the 163

(23%) randomized patients had either IGT or IFG.7Patients were randomized to receive

exenatide (10 g with a 4-week, 5-g dose-initiation period) or placebo, administeredtwice daily, 1 dose before morning meals and 1 before evening meals. Both groups also

followed a structured program of diet and physical activity. Patients taking exenatide lost

5.1 kg from baseline vs 1.6 kg with placebo (P10%).2Low-

dose aspirin (75-162 mg daily) is recommended for all persons with prediabetes for

whom there is no identified excess risk for gastrointestinal, intracranial, or other

hemorrhagic condition.1

Blood Pressure Management

For most patients with prediabetes, blood pressure goals are the same as for T2DM:


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Therapeutic recommendations for hypertension start with lifestyle modification, including

the DASH diet (Dietary Approaches to Stop Hypertension), reduced salt intake, increased

physical activity, and consultation with a registered dietitian and/or CDE as needed.2

Some patients with prediabetes will require medication to achieve target blood

pressure.2,17Hypertension is common among individuals with prediabetes and, given thehigh rates of CVD in prediabetes, should be managed as aggressively and with the same

agents as overt T2DM.2Due to their renal and/or CVD benefits, drugs such as

angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers are

preferred for patients with prediabetes. Other antihypertensive drugs such as

vasodilating beta-adrenergic blockers, calcium channel blockers, diuretics, and centrally

acting agents should be used as necessary. Multiple agents may be necessary to achieve

blood pressure targets.

Dyslipidemia

Treatment targets for dyslipidemia are based on established CVD risk reduction

recommendations.2

In persons with prediabetes and no CVD or minimal CVD risk, a LDL cholesterol goal of


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Low HDL-C is common in prediabetes. Nicotinic acid is effective in raising HDL-C, but it

increases insulin resistance and may accelerate the appearance of overt T2DM.2

Medical Weight Loss

When diet and lifestyle interventions fail to achieve the desired weight loss, someclinicians may choose to use pharmacologic agents approved for weight loss.

Orlistat.Orlistat is a lipase inhibitor that has been shown to foster additional weight loss

compared with lifestyle modifications alone.21There is evidence that orlistat, approved

for use in the United States in 1999, prevents progression from prediabetes to diabetes.1

In 3 studies, orlistat reduced conversion rates from IGT or IFG to T2DM. One of these

studies reported a reduction from 10.9% to 5.2% (P=0.041) in the conversion rate to

T2DM. Similarly, another study reported a reduction in conversion rate to T2DM from

9.0% to 6.2%, with a risk reduction of 37.3% (P=0.0032).2,21,22One review of 28 studies

comparing orlistat and placebo found a 3.9-kg weight loss favoring orlistat in patients at

low risk for CVD, a 2.5-kg weight loss favoring orlistat in patients with T2DM, and a 2.0-

kg weight loss favoring orlistat in patients at high risk for CVD.2,23

Orlistat therapy is also associated with decreases in A1C; in 1 study, A1C decreased by

1.1% in the orlistat group vs 0.2% in the control group. In this study, orlistat therapy

also resulted in a mean weight loss of 5% of body weight.2

Lorcaserin.Lorcaserin, approved in the United States in 2012 for use in weight

management, is a selective serotonin 2C agonist. It is indicated for use in either obese

(BMI 30 kg/m

2

) or overweight (BMI 27 kg/m

2

) patients with 1 weight-relatedcomorbid condition (such as dyslipidemia, hypertension, glucose intolerance, CVD, or

sleep apnea).24

In phase 3 lorcaserin studies, which included 7190 patients treated for up to 2 years,

47.1% of patients treated with 10 mg twice daily lost 5% of their baseline body weight,

compared with 22.6% of patients treated with placebo (P50 years for phentermine and >13 years for

topiramate).25Phentermine/topiramate was originally called Qnexa and has now been

renamed Qsymia. As its primary mechanism of action for weight loss, phentermine

induces an anorectic effect through the release of hypothalamic norepinephrine. In

contrast, topiramate causes increased satiety due to decreased gastrointestinal motility,

increased taste aversion, increased energy expenditure, and decreased caloric intake.


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Phentermine/topiramate is recommended for obese (BMI 30 kg/m2) or overweight

(BMI 27 kg/m2) patients with weight-related comorbidities such as central adiposity

(abdominal obesity), dyslipidemia, hypertension, or T2DM.25

In 3 phase 3 trials, dose-related improvements in obesity-related comorbidities such as

blood pressure, lipids, and diabetes markers were observed (intent-to-treatlastobservation carried forward [ITT-LOCF] data).25Significant and dose-related

improvements in cardiovascular, metabolic, glycemic, and inflammatory end points were

obtained with phentermine/ topiramate therapy and maintained throughout the 56

weeks of treatment.

Among phentermine/topiramatetreated patients in phase 3 trials, 45% to 70%

achieved the 5% weight-loss threshold.25Among patients without a diagnosis of T2DM

at study entry, progression to T2DM occurred in 9.9% of placebo-treated patients vs

6.6% of phentermine/topiramatetreated patients (relative risk 0.66; 95% confidence

interval 0.53-0.83). Therefore, in these studies, phentermine/topiramate treatmentresulted in a 41% decrease in the annualized incidence of T2DM.

Surgical Weight Loss

Bariatric surgery is effective in reducing the likelihood of diabetes development in

patients who are morbidly obese (BMI >40 kg/m2) or who have other significant risk

factors. However, the members of the committee of The American College of

Endocrinology (ACE) Task Force on the Prevention of Diabetes do not believe that a

general recommendation is appropriate for patients with prediabetes.1However,

evidence does suggest that surgical intervention in obesity significantly reduces T2DM

risk, as well as the risk of future mortality, and is cost-effective.2,26,27

The beneficial effect of bariatric surgery on T2DM prevention has been confirmed in a

number of studies.2

The prospective, controlled Swedish Obese Subjects (SOS) Study compared obese

subjects who underwent gastric surgery with matched, conventionally treated obese

control subjects (FPG at baseline for individuals enrolled for 10 years: control group

5.3 +/- 1.8 mmol/L, surgical group 5.4 +/- 2.0 mmol/L). Four thousand forty-seven

patients were enrolled for at least a 2-year follow-up period, and 1703 patients were

enrolled for at least 10 years of follow-up. The actual follow-up rate was 86.6% at 2

years and 74.5% at 10 years.28After 2 years, the SOS reported a T2DM incidence rate of

8% in the control group vs 1% in the surgical group (P


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This study indicates that bariatric surgery is a favorable option in the treatment of

severe obesity. The 2-, 10-, and 15-year rates of recovery from all evaluated risk factors

were more favorable in the surgery group than in the control group, with the exception

of hypercholesterolemia. Similarly, the 2- and 10-year incidence rates of

hypertriglyceridemia, diabetes, and hyperuricemia were more favorable in the surgery

group vs the control group.28,29

AACE recommends bariatric surgery only for obese patients:

Laparoscopic-assisted gastric banding for patients with a BMI >30 kg/m2or Roux-en-Y

gastric bypass for those with a BMI >35 kg/m2.

Patients who undergo Roux-en-Y gastric bypass must have meticulous metabolic

postoperative follow-up because of a risk of vitamin and mineral deficiencies and

hypoglycemia.2

Management of Children and Adolescents With Prediabetes

The management of children or adolescents at increased risk for T2DM should apply

many of the same measures recommended to prevent or delay the progression to

diabetes in adults at elevated risk.1In these patients, emphasis must be placed primarily

on lifestyle change, which can be beneficial in improving glycemic and cardiovascular risk

parameters. Although there have been few interventional studies among children that

are directed at reducing diabetes and/or cardiovascular risk, the increased incidence

ofT2DMin this age group parallels an increase in obesity, which has been attributed to

increased caloric consumption and diminished exercise/activity.

References

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the continuum of hyperglycemia: when do the risks of diabetes begin? A consensus

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Clinical Endocrinologists. Endocr Pract. 2008;14:933-946.

2. Handelsman Y, Mechanick JI, Blonde L, et al. American Association of Clinical

Endocrinologists medical guidelines for clinical practice for developing a diabetes mellitus

comprehensive care plan. Endocr Pract. 2011;17(Suppl 2):1-53.

3. Mann DM, Lin JJ. Increasing efficacy of primary care-based counseling for diabetes

prevention: rationale and design of the ADAPT (Avoiding Diabetes Through Action Plan

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4. Ali MK, Echouffo-Tcheugui J, Williamson DF. How effective were lifestyle interventions in

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5. Diabetes Prevention Program Research Group. 10-year follow-up of diabetes incidence

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6. Goldberg RM, Cheng AYY, Punthaker Z, Clement M. Use of glycated hemoglobin (A1C) in

the diagnosis of type 2 diabetes mellitus in adults. Can J Diabetes. 2010;July:247-249.

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on body weight and glucose tolerance in obese subjects with and without pre-

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Keech A, Simes RJ, Barter P, et al. Effects of long-term fenofibrate therapy on

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metabolic syndrome: the Fenofibrate Intervention and Event Lowering in Diabetes

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23.Hutton B, Fergusson D. Changes in body weight and serum lipid profile in obese patients

treated with orlistat in addition to a hypocaloric diet: a systematic review of randomized

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24.US Food and Drug Administration. Lorcaserin hydrochloride (APD356). NDA 22-529.

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ugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM225635.pdf.

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Tice JA, Karliner L, Walsh J, Petersen AJ, Feldman MD. Gastric banding or bypass? A

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diabetes in Swedish obese subjects. N Engl J Med. 2012;367:695-704.

http://outpatient.aace.com/prediabetes/management-of-prediabetes
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM225635.pdfhttp://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM225635.pdfhttp://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM225635.pdfhttp://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM225635.pdfhttp://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM218821.pdfhttp://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM218821.pdfhttp://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM218821.pdfhttp://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM218821.pdfhttp://outpatient.aace.com/prediabetes/management-of-prediabeteshttp://outpatient.aace.com/prediabetes/management-of-prediabeteshttp://outpatient.aace.com/prediabetes/management-of-prediabeteshttp://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM218821.pdfhttp://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM218821.pdfhttp://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM225635.pdfhttp://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM225635.pdf

Management of Prediabetes

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