Prevention of Type 2 Diabetes Mellitus by Changes in Diet
Primary Purpose
Prediabetes
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Diet
Sponsored by

About this trial
This is an interventional prevention trial for Prediabetes
Eligibility Criteria
Inclusion Criteria: Adults over 20 years Exclusion Criteria: Diet therapy; severe physical activity; accompanying diseases such as cancer which reduce their life expectancy; receiving thiazide diuretics; receiving systemic ß blockers; receiving glucocorticoids; receiving nicotinic acid; receiving weight lowering drugs
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
No Intervention
Arm Label
Study group 1
Study group 2
Control Group
Arm Description
Received high monounsaturated fat diet
Received high carbohydrate diet
Control group was encouraged to follow the Food Guide Pyramid
Outcomes
Primary Outcome Measures
Incidence of Diabetes in 322 Subjects with Prediabetes
Secondary Outcome Measures
Full Information
NCT ID
NCT02250066
First Posted
September 17, 2014
Last Updated
July 16, 2017
Sponsor
Ilam University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02250066
Brief Title
Prevention of Type 2 Diabetes Mellitus by Changes in Diet
Official Title
Effect of Diet Therapy on Prevention of Type 2 Diabetes Mellitus Among 322 Adults Over 20 Years With Abnormal Glucose Metabolism
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ilam University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
investigators evaluated the efficacy of two types of diet with different macronutrients, on prevention or delaying the onset of type 2 diabetes in subjects with either impaired fasting glucose (IFG) or impaired glucose tolerance (IGT). 322 subjects with prediabetes were randomly assigned to high monounsaturated fat diet (n=107), high carbohydrate diet (n=106) or control group (n=109) and followed for 2 years. For calculating daily energy requirement in subjects with BMI≥25 kg/m2 the weight was adjusted with the use of 110 percent of the ideal body weight with no attempt for losing body weight. Control group were encouraged to follow the Food Guide Pyramid and reduce their fat intake to less than 30% of energy consumed and saturated fat to less than 10 percent of total energy. The primary outcome variable was incidence of type 2 diabetes mellitus, diagnosed by the latest American Diabetic Association criteria.
Detailed Description
322 participants were randomized and stratified into a control group and two study groups according to sex, age, body mass index (BMI), IFG and IGT or both. Baseline assessments were anthropometric measurements, food diary and laboratory exams. Anthropometric measurements were repeated annually. Blood sample tests measured fasting blood glucose, glucose two hours after ingestion of 75 g glucose, high density lipoprotein (HDL), low density lipoprotein (LDL) and triglyceride (TG), which were analyzed in the laboratory of the only university hospital in the city. The same assessments were repeated annually (at 12 and 24 months) in all groups. Daily energy requirement was calculated by multiplying 30-35 Kcal per Kg body weight for each participant. For patients with BMI ≥25 kg/m2, the weight was adjusted with use of 110 percent of the ideal body weight. Diet in HCD group was 15% from protein, 30% from fat (10% MUFA, 10% PUFA, 10% SFA) and 55% from carbohydrate. Diet in HMD group was 15% from protein, 45% from fat (25% MUFA, 10% PUFA, 10% SFA) and 40% from carbohydrate. Source of MUFA in this group was olive oil. In the intervention groups diet regimen was written for each participant by a registered dietitian. Group three or the control group was encouraged to follow the Food Guide Pyramid and reduce their fat intake to less than 30 percent of energy consumption and saturated fat to less than 10 percent of total energy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
322 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study group 1
Arm Type
Other
Arm Description
Received high monounsaturated fat diet
Arm Title
Study group 2
Arm Type
Other
Arm Description
Received high carbohydrate diet
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Control group was encouraged to follow the Food Guide Pyramid
Intervention Type
Other
Intervention Name(s)
Diet
Intervention Description
Study group 1 received high monounsaturated fat diet Study group2 received high carbohydrate diet Control group was encouraged to follow the Food Guide Pyramid
Primary Outcome Measure Information:
Title
Incidence of Diabetes in 322 Subjects with Prediabetes
Time Frame
Up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adults over 20 years Exclusion Criteria: Diet therapy; severe physical activity; accompanying diseases such as cancer which reduce their life expectancy; receiving thiazide diuretics; receiving systemic ß blockers; receiving glucocorticoids; receiving nicotinic acid; receiving weight lowering drugs
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prevention of Type 2 Diabetes Mellitus by Changes in Diet
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