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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)

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ClinicalTrials.gov Identifier: NCT01121471
Recruitment Status : Completed
First Posted : May 12, 2010
Last Update Posted : May 12, 2010
Sponsor:
Collaborator:
Cognis
Information provided by:
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).

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Dietary Supplement: Conjugated Linoleic Acid (CLA) Dietary Supplement: Safflower OIl Not Applicable

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  (Clinical Trial)
Actual Enrollment : 55 participants
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)
Study Start Date : December 2004
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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 :
  1. change in insulin sensitivity [ Time Frame: baseline and every 4 weeks until week 16 ]
  2. change in glucose tolerance [ Time Frame: baseline and every 4 weeks for 16 weeks ]
  3. change in HbA1c [ Time Frame: baseline and week 16 ]
  4. change in blood lipid profile [ Time Frame: baseline and every 4 weeks for 16 weeks ]
  5. change in serum adipocytokines [ Time Frame: baseline and every 4 weeks for 16 weeks ]
  6. change in hepatic enzymes [ Time Frame: baseline and every 4 weeks for 16 weeks ]
  7. change in body composition [ Time Frame: baseline and every 4 weeks for 16 weeks ]


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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

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

Publications of Results:
Responsible Party: Martha A. Belury, The Ohio State University
ClinicalTrials.gov Identifier: NCT01121471     History of Changes
Other Study ID Numbers: 2003H0122
First Posted: May 12, 2010    Key Record Dates
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