Dietary Interventions in Type 2 Obese Diabetic Patients in the Community

NCT00520182 | Unknown Phase 3

• 1 other identifier: RCT3645
• Study Type: interventional
• Target: 259
• Locations: 1 country
• Sites: 1

Brief Summary

Obese patients with type 2 diabetes often fail to loose weight and thus do not succeed in improving their sugar and lipid profiles and remain at high risk for diabetes complications The study enrolled 259 obese diabetic patients attending HMO clinics in central Israel. Over a 6 month period the participants met with a dietitian every fortnight and attended group lectures every 2 months. The objective of this intervention was to compare three dietary intervention along with close monitoring of the patients by dietitians, regarding blood lipid and sugar balance as well as weight loss. The three diets are the American Diabetes Association (ADA) diet from 2003; a diet containing low glycemic index carbohydrate otherwise similar to the ADA diet; and a low glycemic index diet with more fat than the other 2 diets with high proportion of mono-unsaturated fatty acids. Patients were individually randomized to receive one of the three diets. Among the measures obtained every 3 months for the first year and every 6 months thereafter are weight, fasting insulin and glucose, glycosylated hemoglobin, blood and urine chemistry profiles and lipid profile.

Conditions

Diabetes Type 2

Outcome Measures

Primary Outcomes (1)

• Triglyceride level, glycated hemoglobin level, fasting plasma glucose

  baseline and every 3 months during year 1, every 6 months therafter

Secondary Outcomes (1)

• Weight, BMI, waist hip circumference, insulin resistance using HOMA (fasting glucose to fasting insulin ration), HDL-Cholesterol level.

  baseline, every 3 months in year 1, every 6 months therafter

Study Arms (3)

1

ACTIVE COMPARATOR

ADA 2003 diet

Behavioral: ADA 2003

2

ACTIVE COMPARATOR

Low Glycemic index (LGI) diet

Behavioral: Low Glycemic index (LGI) diet

3

ACTIVE COMPARATOR

MUFA diet

Behavioral: MUFA diet

Interventions

MUFA diet BEHAVIORAL

Patients were advised to consume 23 cal/kg/day. The diet contained sodium (up to 3000mg/day), potassium (more than 3000 mg/day), calcium (around 1300 mg/day) and magnesium (more than 800 mg/day). MUFA diet included only low glycemic index carbohydrates. The diet consisted of 35% carbohydrates and 45% fat (50% of them were mono-unsaturated fatty acids \[MUFA\]). Participants were advised to eat 4-6 meals per day according to their lifestyle and to participate in 30-45 min of aerobic activity at least 3 days a week.

3

ADA 2003 BEHAVIORAL

Patients were advised to consume 23 cal/kg/day. The diet contained sodium (up to 3000mg/day), potassium (more than 3000 mg/day), calcium (around 1300 mg/day) and magnesium (more than 800 mg/day). The carbohydrates are with mixed glycemic index. The diet contains 50-55% carbohydrates, 30% fat and 15-20% protein. Participants were advised to eat 4-6 meals per day according to their lifestyle and to participate in 30-45 min of aerobic activity at least 3 days a week.

1

Low Glycemic index (LGI) diet BEHAVIORAL

Patients were advised to consume 23 cal/kg/day. The diet contained sodium (up to 3000mg/day), potassium (more than 3000 mg/day), calcium (around 1300 mg/day) and magnesium (more than 800 mg/day). LGI diet included only low glycemic index carbohydrates. The diet consisted of 50-55% carbohydrates, 30% fat and 20%. protein. Participants were advised to eat 4-6 meals per day according to their lifestyle and to participate in 30-45 min of aerobic activity at least 3 days a week.

2

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 30-65years
• DM2 diagnosed within 1-10 years
• Body mass index (BMI) 27-34 kg/m²
• Last HbA1c measurement 7%-10%
• Last plasma triglyceride (TG) levels 160-400 mg/dl
• Last serum creatinine less than 1.4 mg/dl
• No change in diabetes medication for at least three months before entering the study

You may not qualify if:

• Proliferative diabetic retinopathy
• Current insulin treatment
• Active oncologic or psychiatric disease
• Uncontrolled hypothyroidism or hyperthyroidism

Sponsors & Collaborators

• Ben-Gurion University of the Negev: lead
• The S. Daniel Abraham International Center for Health and Nutrition: collaborator
• Clalit Health Services: collaborator

Study Sites (1)

Clalit HMO

Rehovot, Petach Tikva, Ramle, Central District, Israel

Location

Related Publications (2)

• Shahar DR, Abel R, Elhayany A, Vardi H, Fraser D. Does dairy calcium intake enhance weight loss among overweight diabetic patients? Diabetes Care. 2007 Mar;30(3):485-9. doi: 10.2337/dc06-1564.

  PMID: 17327309 RESULT

• Elhayany A, Lustman A, Abel R, Attal-Singer J, Vinker S. A low carbohydrate Mediterranean diet improves cardiovascular risk factors and diabetes control among overweight patients with type 2 diabetes mellitus: a 1-year prospective randomized intervention study. Diabetes Obes Metab. 2010 Mar;12(3):204-9. doi: 10.1111/j.1463-1326.2009.01151.x.

  PMID: 20151996 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Diet

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Drora Fraser, PhD

  Ben-Gurion University of the Negev

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 22, 2007
• First Posted: August 23, 2007
• Study Start: March 1, 2004
• Study Completion: February 1, 2008
• Last Updated: September 20, 2007

Record last verified: 2007-09

Locations

IL (1)