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

• Sponsor: Ohio State University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01121471
• Collaborator: Cognis (Industry)
• Enrollment: 55
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Dec 1, 2004
• Actual Primary Completion Date: Nov 1, 2006
• Actual Study Completion Date: Nov 1, 2006

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. change in insulin sensitivity [baseline and every 4 weeks until week 16]

2. change in glucose tolerance [baseline and every 4 weeks for 16 weeks]

3. change in HbA1c [baseline and week 16]

4. change in blood lipid profile [baseline and every 4 weeks for 16 weeks]

5. change in serum adipocytokines [baseline and every 4 weeks for 16 weeks]

6. change in hepatic enzymes [baseline and every 4 weeks for 16 weeks]

7. change in body composition [baseline and every 4 weeks for 16 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01121471
• Other Study ID Numbers: 2003H0122
• First Posted: May 12, 2010
• Last Update Posted: May 12, 2010
• Last Verified: May 1, 2010

• Keywords provided by , ,: diabetes; conjugated linoleic acid
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of May 12, 2010