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

NCT00795691 | Completed DMC

• 1 other identifier: 2002-180
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes

Keywords

diabetes; low-carbohydrate diet; weight loss; obesity; dietary intervention

Outcome Measures

Primary Outcomes (6)

• Hemoglobin A1c at month 3

  Hemoglobin A1c (HbA1c) is a form of hemoglobin (a blood pigment that carries oxygen) that is bound to glucose. HbA1c level indicates blood glucose levels over the previous 2 - 3 months. HbA1c values between 4 and 5.6 are considered normal. HbA1c values greater than 6.5 indicate diabetes.

  3 months into treatment

• Hemoglobin A1c at month 6

  Hemoglobin A1c (HbA1c) is a form of hemoglobin (a blood pigment that carries oxygen) that is bound to glucose. HbA1c level indicates blood glucose levels over the previous 2 - 3 months. HbA1c values between 4 and 5.6 are considered normal. HbA1c values greater than 6.5 indicate diabetes.

  6 months into treatment

• Hemoglobin A1c at month 12

  Hemoglobin A1c (HbA1c) is a form of hemoglobin (a blood pigment that carries oxygen) that is bound to glucose. HbA1c level indicates blood glucose levels over the previous 2 - 3 months. HbA1c values between 4 and 5.6 are considered normal. HbA1c values greater than 6.5 indicate diabetes.

  12 months into treatment

• Change in Body Weight at month 3

  Change in body weight often reflects the effects of dietary changes. Generally, an increase in body weight is correlated with increasing blood glucose levels while a decrease in body weight correlates to decreasing blood glucose levels. Dietary changes that result in decreased body weight will be associated with better glucose control.

  Baseline and 3 months into treatment

• Change in Body Weight at month 6

  Change in body weight often reflects the effects of dietary changes. Generally, an increase in body weight is correlated with increasing blood glucose levels while a decrease in body weight correlates to decreasing blood glucose levels. Dietary changes that result in decreased body weight will be associated with better glucose control.

  Baseline and 6 months into treatment

• Change in Body Weight at month 12

  Change in body weight often reflects the effects of dietary changes. Generally, an increase in body weight is correlated with increasing blood glucose levels while a decrease in body weight correlates to decreasing blood glucose levels. Dietary changes that result in decreased body weight will be associated with better glucose control.

  Baseline and 12 months into treatment

Secondary Outcomes (28)

• Change in Body Fat at month 6

  Baseline and 6 months into treatment

• Change in Body Fat at month 12

  Baseline and 12 months into treatment

• Change in Lean Body Mass at month 6

  Baseline and 6 months into treatment

• Change in Lean Body Mass at month 12

  Baseline and 12 months into treatment

• Change in antidiabetic medication dosage at month 3

  Baseline and 3 months into treatment

Study Arms (2)

Low-carbohydrate diet

EXPERIMENTAL

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.

Behavioral: low-carbohydrate diet

Low-fat diet

ACTIVE COMPARATOR

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.

Behavioral: low-fat diet

Interventions

low-carbohydrate diet BEHAVIORAL

ketogenic low-carbohydrate diet in patients with type 2 diabetes

Low-carbohydrate diet

low-fat diet BEHAVIORAL

low-fat diet in patients with type 2 diabetes

Low-fat diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• Robert C. Atkins Foundation: collaborator

Study Sites (1)

Albert Einstein College of Medicine, General Clinical Research Center

The Bronx, New York, 10461, United States

Location

Related Publications (5)

• Cunningham C, Johnson S, Cowell B, Soroudi N, Segal-Isaacson CJ, Davis NJ, Isasi CR, Wylie-Rosett J. Menu plans in a diabetes self-management weight loss program. J Nutr Educ Behav. 2006 Jul-Aug;38(4):264-6. doi: 10.1016/j.jneb.2006.01.013. No abstract available.

  PMID: 16785099 BACKGROUND

• Davis NJ, Cohen HW, Wylie-Rosett J, Stein D. Serum potassium changes with initiating low-carbohydrate compared to a low-fat weight loss diet in type 2 diabetes. South Med J. 2008 Jan;101(1):46-9. doi: 10.1097/SMJ.0b013e31815d2696.

  PMID: 18176291 BACKGROUND

• Davis NJ, Tomuta N, Schechter C, Isasi CR, Segal-Isaacson CJ, Stein D, Zonszein J, Wylie-Rosett J. Comparative study of the effects of a 1-year dietary intervention of a low-carbohydrate diet versus a low-fat diet on weight and glycemic control in type 2 diabetes. Diabetes Care. 2009 Jul;32(7):1147-52. doi: 10.2337/dc08-2108. Epub 2009 Apr 14.

  PMID: 19366978 RESULT

• Davis NJ, Tomuta N, Isasi CR, Leung V, Wylie-Rosett J. Diabetes-specific quality of life after a low-carbohydrate and low-fat dietary intervention. Diabetes Educ. 2012 Mar-Apr;38(2):250-5. doi: 10.1177/0145721711436132. Epub 2012 Feb 7.

  PMID: 22316641 DERIVED

• Davis NJ, Crandall JP, Gajavelli S, Berman JW, Tomuta N, Wylie-Rosett J, Katz SD. Differential effects of low-carbohydrate and low-fat diets on inflammation and endothelial function in diabetes. J Diabetes Complications. 2011 Nov-Dec;25(6):371-6. doi: 10.1016/j.jdiacomp.2011.08.001. Epub 2011 Oct 27.

  PMID: 22036100 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Weight Loss; Obesity

Interventions

Diet, Carbohydrate-Restricted; Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Judith Wylie-Rosett

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Epidemiology and Population Health

Study Record Dates

• First Submitted: November 20, 2008
• First Posted: November 21, 2008
• Study Start: May 1, 2004
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2008
• Last Updated: July 12, 2019

Record last verified: 2019-07

Locations

US (1)