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

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Dietary Supplement: Safflower OIl; Dietary Supplement: Conjugated Linoleic Acid (CLA)

• Registration Number: NCT01121471
• Lead Sponsor: Ohio State University

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 Timeline

• Study Start: 2004-12
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2010-05
• Study First Submitted: 2010-05-10
• Study First Submitted QC: 2010-05-10
• Last Update Submitted: 2010-05-10
• Study First Posted: 2010-05-12
• Last Update Posted: 2010-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Safflower Oil	Safflower OIl	8.0 g/day safflower oil
CLA 6.4g/day	Conjugated Linoleic Acid (CLA)	Conjugated linoleic acid at a dose of 6.4g/day in a supplement with a total of 8.0g oil

Primary Outcome Measures

Name	Time	Method
change in plasma glucose AUC	baseline and week 16	significant change in plasma glucose AUC (0-3 h) from baseline to Week 16.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The Ohio State University; 🇺🇸 Columbus, Ohio, United States