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

May 10, 2010 updated by: Ohio State University
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Safflower Oil
8.0 g/day safflower oil
Dietary supplement: Safflower OIl
8.0g/day safflower oil
Experimental: CLA 6.4g/day
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)
6.4 g CLA/day, capsule form, for 16 week arms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline and week 16

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Collaborators

Cognis

Investigators

  • Principal Investigator: Martha A. Belury, PhD, Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

May 10, 2010

First Submitted That Met QC Criteria

May 10, 2010

First Posted (Estimate)

May 12, 2010

Study Record Updates

Last Update Posted (Estimate)

May 12, 2010

Last Update Submitted That Met QC Criteria

May 10, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2003H0122

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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