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Dietary Interventions in Type 2 Obese Diabetic Patients in the Community (DIPAC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by Ben-Gurion University of the Negev.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
The S. Daniel Abraham International Center for Health and Nutrition
Clalit Health Services
Information provided by:
Ben-Gurion University of the Negev
ClinicalTrials.gov Identifier:
NCT00520182
First received: August 22, 2007
Last updated: September 19, 2007
Last verified: September 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes Type 2
 Behavioral: MUFA diet
Behavioral: ADA 2003
Behavioral: Low Glycemic index (LGI) diet
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Community Trial to Assess the Effect of Nutritional Intervention Models on Medical Outcomes Among Obese Type 2 Diabetic Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ben-Gurion University of the Negev:

Primary Outcome Measures:
  • Triglyceride level, glycated hemoglobin level, fasting plasma glucose [ Time Frame: baseline and every 3 months during year 1, every 6 months therafter ]

Secondary Outcome Measures:
  • Weight, BMI, waist hip circumference, insulin resistance using HOMA (fasting glucose to fasting insulin ration), HDL-Cholesterol level. [ Time Frame: baseline, every 3 months in year 1, every 6 months therafter ]

Enrollment: 259
Study Start Date: March 2004
Estimated Study Completion Date: February 2008
Arms Assigned Interventions
Active Comparator: 1
ADA 2003 diet
 Behavioral: ADA 2003
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.
Active Comparator: 2
Low Glycemic index (LGI) diet
 Behavioral: Low Glycemic index (LGI) diet
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.
Active Comparator: 3
MUFA diet
 Behavioral: MUFA diet
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.

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Proliferative diabetic retinopathy
  2. Current insulin treatment
  3. Active oncologic or psychiatric disease
  4. Uncontrolled hypothyroidism or hyperthyroidism
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00520182

Locations
Israel
Clalit HMO
Rehovot, Petach Tikva, Ramle, Central region, Israel
Sponsors and Collaborators
Ben-Gurion University of the Negev
The S. Daniel Abraham International Center for Health and Nutrition
Clalit Health Services
Investigators
Study Chair: Drora Fraser, PhD Ben-Gurion University of the Negev
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00520182     History of Changes
Other Study ID Numbers: RCT3645
Study First Received: August 22, 2007
Last Updated: September 19, 2007
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013