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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:
Collaborator:
Cognis
Information provided by:
Ohio State University
ClinicalTrials.gov Identifier:
NCT01121471
First received: May 10, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • change in plasma glucose AUC [ Time Frame: baseline and week 16 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • change in glucose tolerance [ Time Frame: baseline and every 4 weeks for 16 weeks ] [ Designated as safety issue: No ]
  • change in HbA1c [ Time Frame: baseline and week 16 ] [ Designated as safety issue: No ]
  • change in blood lipid profile [ Time Frame: baseline and every 4 weeks for 16 weeks ] [ Designated as safety issue: No ]
  • change in serum adipocytokines [ Time Frame: baseline and every 4 weeks for 16 weeks ] [ Designated as safety issue: No ]
  • change in hepatic enzymes [ Time Frame: baseline and every 4 weeks for 16 weeks ] [ Designated as safety issue: Yes ]
  • change in body composition [ Time Frame: baseline and every 4 weeks for 16 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: May 10, 2010
Last Updated: May 10, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 19, 2013