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

Primary Purpose

Diabetes Type 2

Status
Unknown status
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
MUFA diet
ADA 2003
Low Glycemic index (LGI) diet
Sponsored by
Ben-Gurion University of the Negev
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Type 2

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clalit HMO

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

ADA 2003 diet

Low Glycemic index (LGI) diet

MUFA diet

Outcomes

Primary Outcome Measures

Triglyceride level, glycated hemoglobin level, fasting plasma glucose

Secondary Outcome Measures

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

Full Information

First Posted
August 22, 2007
Last Updated
September 19, 2007
Sponsor
Ben-Gurion University of the Negev
Collaborators
The S. Daniel Abraham International Center for Health and Nutrition, Clalit Health Services
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1. Study Identification

Unique Protocol Identification Number
NCT00520182
Brief Title
Dietary Interventions in Type 2 Obese Diabetic Patients in the Community
Acronym
DIPAC
Official Title
Community Trial to Assess the Effect of Nutritional Intervention Models on Medical Outcomes Among Obese Type 2 Diabetic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Unknown status
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Ben-Gurion University of the Negev
Collaborators
The S. Daniel Abraham International Center for Health and Nutrition, Clalit Health Services

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Type 2

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
259 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
ADA 2003 diet
Arm Title
2
Arm Type
Active Comparator
Arm Description
Low Glycemic index (LGI) diet
Arm Title
3
Arm Type
Active Comparator
Arm Description
MUFA diet
Intervention Type
Behavioral
Intervention Name(s)
MUFA diet
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ADA 2003
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Low Glycemic index (LGI) diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Triglyceride level, glycated hemoglobin level, fasting plasma glucose
Time Frame
baseline and every 3 months during year 1, every 6 months therafter
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Proliferative diabetic retinopathy Current insulin treatment Active oncologic or psychiatric disease Uncontrolled hypothyroidism or hyperthyroidism
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Drora Fraser, PhD
Organizational Affiliation
Ben-Gurion University of the Negev
Official's Role
Study Chair
Facility Information:
Facility Name
Clalit HMO
City
Rehovot, Petach Tikva, Ramle
State/Province
Central region
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
17327309
Citation
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.
Results Reference
result
PubMed Identifier
20151996
Citation
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.
Results Reference
derived

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Dietary Interventions in Type 2 Obese Diabetic Patients in the Community

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