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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) (WDS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01121471
First Posted: May 12, 2010
Last Update Posted: May 12, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Cognis
Information provided by:
Ohio State University
  Purpose
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).

Condition Intervention
Diabetes Mellitus Dietary Supplement: Conjugated Linoleic Acid (CLA) Dietary Supplement: Safflower OIl

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Supplementation With Conjugated Linoleic Acid (CLA) as Complementary Therapy in the Management of Type 2 Diabetes Mellitus (Women's Diabetes Study)

Resource links provided by NLM:


Further study details as provided by Ohio State University:

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

Enrollment: 55
Study Start Date: December 2004
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01121471


Locations
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Cognis
Investigators
Principal Investigator: Martha A. Belury, PhD Ohio State University
  More Information

Publications:
Responsible Party: Martha A. Belury, The Ohio State University
ClinicalTrials.gov Identifier: NCT01121471     History of Changes
Other Study ID Numbers: 2003H0122
First Submitted: May 10, 2010
First Posted: May 12, 2010
Last Update Posted: May 12, 2010
Last Verified: May 2010

Keywords provided by Ohio State University:
diabetes
conjugated linoleic acid

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases