Supplementation With Conjugated Linoleic Acid (CLA) as Complementary Therapy in the Management of Type 2 Diabetes Mellitus (Women's Diabetes Study)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ohio State University
- Enrollment
- 55
- Locations
- 2
- Primary Endpoint
- change in plasma glucose AUC
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •diagnosis of Type 2 diabetes mellitus
- •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
Outcomes
Primary Outcomes
change in plasma glucose AUC
Time Frame: baseline and week 16
significant change in plasma glucose AUC (0-3 h) from baseline to Week 16.
Secondary Outcomes
- 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)