Supplementation With Conjugated Linoleic Acid (CLA) as Complementary Therapy in the Management of Type 2 Diabetes Mellitus (Women's Diabetes Study)

Study Overview
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Brief Summary
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The purpose of this study is to determine the role of CLA as a complementary therapy to improve body composition, glucose tolerance, fasting plasma glucose and insulin, and hemoglobinA1c (HbA1c) in subjects with type 2 diabetes mellitus (T2DM).

Detailed Description
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The design is a double-blind, placebo-controlled, crossover study conducted at a single site. The primary variable is a change from baseline to Week 16 in plasma glucose area under the curve during a three-hour oral glucose tolerance test. Secondary variables include changes in fasting levels of glucose and insulin, glucose tolerance, hemoglobinA1c, hepatic enzymes, adipocytokines, blood lipid profile, and body composition. Supporting endpoints include dietary intake, physical activity, fatty acids, and vital signs.

Official Title
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Supplementation With Conjugated Linoleic Acid (CLA) as Complementary Therapy in the Management of Type 2 Diabetes Mellitus (Women's Diabetes Study)

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Dietary Supplement: Conjugated Linoleic Acid (CLA)
* Dietary Supplement: Safflower OIl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of Type 2 diabetes mellitus obese postmenopausal HbA1c >6.49 and <14.1 Exclusion Criteria: use of tobacco substance abuse impaired cognitive function renal disease abnormal liver function gastrointestinal diseases use of exogenous insulin use of hormone replacement therapy currently or within past 6 months pacemaker/defibrillator

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Safflower Oil<br>8.0 g/day safflower oil | Dietary Supplement: Safflower OIl<br>* 8.0g/day safflower oil<br>|
| Experimental: CLA 6.4g/day<br>Conjugated linoleic acid at a dose of 6.4g/day in a supplement with a total of 8.0g oil | Dietary Supplement: Conjugated Linoleic Acid (CLA)<br>* 6.4 g CLA/day, capsule form, for 16 week arms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in plasma glucose AUC | significant change in plasma glucose AUC (0-3 h) from baseline to Week 16. | baseline and week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in insulin sensitivity |  | baseline and every 4 weeks until week 16 | 
| change in glucose tolerance |  | baseline and every 4 weeks for 16 weeks | 
| change in HbA1c |  | baseline and week 16 | 
| change in blood lipid profile |  | baseline and every 4 weeks for 16 weeks | 
| change in serum adipocytokines |  | baseline and every 4 weeks for 16 weeks | 
| change in hepatic enzymes |  | baseline and every 4 weeks for 16 weeks | 
| change in body composition |  | baseline and every 4 weeks for 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, conjugated linoleic acid