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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

August 22, 2007
September 19, 2007
March 2004
Not Provided
Triglyceride level, glycated hemoglobin level, fasting plasma glucose [ Time Frame: baseline and every 3 months during year 1, every 6 months therafter ]
Triglyceride level, glycated hemoglobin level, fasting plasma glucose [ Time Frame: baseline and evry 3 months during year 1, every 6 months therafter ]
Complete list of historical versions of study NCT00520182 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Dietary Interventions in Type 2 Obese Diabetic Patients in the Community
Community Trial to Assess the Effect of Nutritional Intervention Models on Medical Outcomes Among Obese Type 2 Diabetic Patients

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Diabetes Type 2
  • 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.
  • 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.
  • 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: 1
    ADA 2003 diet
    Intervention: Behavioral: ADA 2003
  • Active Comparator: 2
    Low Glycemic index (LGI) diet
    Intervention: Behavioral: Low Glycemic index (LGI) diet
  • Active Comparator: 3
    MUFA diet
    Intervention: Behavioral: MUFA diet

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
259
February 2008
Not Provided

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
Both
30 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00520182
RCT3645
No
Not Provided
Ben-Gurion University of the Negev
  • The S. Daniel Abraham International Center for Health and Nutrition
  • Clalit Health Services
Study Chair: Drora Fraser, PhD Ben-Gurion University of the Negev
Ben-Gurion University of the Negev
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP