Diabetes Dietary Study- Low Carbohydrate and Low-Fat Diets in Type 2 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2008-12-31

Brief Summary

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The purpose of this study is to determine the effects of a low-carbohydrate diet compared to a low-fat/high-carbohydrate diet on glucose control in patients who have Type 2 Diabetes.

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Detailed Description

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Obesity is not only a risk factor for type 2 diabetes but it also frequently increases the need for insulin requirement in people with type 2 diabetes who are overweight or obese. However, since insulin is a lipogenic hormone, insulin or sulfonylurea therapy that increases circulating insulin levels often results in additional weight gain. Controlled-carbohydrate "ketogenic" diets have been popular as an alternative way of losing weight, but little is known about the safety and efficacy of using a ketogenic approach in the management of overweight/obese patients with type 2 diabetes.

The proposed study will randomize a group of 126 overweight or obese (BMI \> 25 and \< 40) adults with type 2 diabetes to either a low-carbohydrate or a low-fat weight loss diet. The primary study endpoint will be six and twelve month changes in glycemic control as measured by hemoglobin A1c (HbA1c). Secondary endpoints include adiposity (BMI, body composition and fat distribution); blood glucose patterns (from self-monitoring records); change in antidiabetic medications (potential decrease in number and dosage), lipids, insulin sensitivity from a meal tolerance test, other metabolic markers (C-reactive protein, leptin) and participants' lifestyle (physical activity and diet) and perceptions of satiety, quality of life, mood, and well-being.

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low-carbohydrate diet

The low-carbohydrate diet was based on the Atkins weight loss diet. The daily intake goals were to restrict intake of carbohydrate to 20-25 grams for the first 2-week phase. If body weight decreased, the daily goal for carbohydrate was increased by 5 grams. If body weight increased, the daily goal for carbohydrate intake was decreased by 5 grams. The minimum goal for carbohydrate intake was 20 grams per day and the maximum goal was 50 grams per day.

Group Type EXPERIMENTAL

low-carbohydrate diet

Intervention Type BEHAVIORAL

ketogenic low-carbohydrate diet in patients with type 2 diabetes

Low-fat diet

The low-fat diet was based on the algorithm used to restrict fat and calorie intake in the Diabetes Prevention Program. The daily goals for fat intake was based on an algorithm to reduce total calorie intake to achieve a one pound weight loss per week with 25% of calories from fat.

Group Type ACTIVE_COMPARATOR

low-fat diet

Intervention Type BEHAVIORAL

low-fat diet in patients with type 2 diabetes

Interventions

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low-carbohydrate diet

ketogenic low-carbohydrate diet in patients with type 2 diabetes

Intervention Type BEHAVIORAL

low-fat diet

low-fat diet in patients with type 2 diabetes

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of type 2 diabetes
* HbA1c 7-10%
* BMI (kg/m2) \> 25 and \< 40 and weight \< 280 lb.
* Skill at and willingness to perform capillary blood glucose self-monitoring ---Insulin (changed to long-acting basal during run-in) or sulfonylurea treatment

Exclusion Criteria

* Age \> 65
* Weight \>280 lb
* Health conditions that may interfere with study participation or for which the study interventions may be contraindicated. These include: kidney stones or kidney disease (creatinine \> 1.3 and 1.5 mg/dL for females and males, respectively; proteinuria \> 300 ug/g creatinine); liver or gall bladder disease; significant heart disease (myocardial infarction in the past six months, prior or current evidence of congestive heart failure, other evidence of left ventricular (LV) dysfunction) or other indices of active cardiac abnormalities, (angina, electrocardiogram evidence of ischemia or transmural myocardial infarction), significant anemia; and cancer (other than effectively treated non melanomatous skin cancer and surgically treated cervical cancer in situ).
* Current hypokalemia defined as serum potassium levels \<3.5 mg/dL.
* Osteoporosis
* Type 1 diabetes (history of ketoacidosis or undetectable fasting C-peptide levels)
* History of severe or repeated hypoglycemia, or hypoglycemia unawareness. Lack of recourse to another person in the immediate vicinity in the unlikely event that they require outside assistance for severe hypoglycemia.
* Triglyceride levels \> 400 mg/dL.
* Inability or unwillingness to comply with any aspects of the dietary and research protocol.
* Weight changes \> 10 lbs in the past three months.
* History of binge eating disorder or other eating disorders.
* Pregnancy or intention to become pregnant in the next 12 months.
* Current oral hypoglycemic medication that raises the blood insulin level

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No