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

Diabetes Mellitus Clinical Trial

— WDS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01121471
• Other study ID #: 2003H0122
• Status: Completed
• Phase: N/A
• First received: May 10, 2010
• Last updated: May 10, 2010
• Start date: December 2004
• Est. completion date: November 2006

Study information

• Verified date: May 2010
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Dietary Supplement:
• Conjugated Linoleic Acid (CLA)
6.4 g CLA/day, capsule form, for 16 week arms
• Safflower OIl
8.0g/day safflower oil

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	Cognis

Country where clinical trial is conducted

United States, 

References & Publications (1)

Norris LE, Collene AL, Asp ML, Hsu JC, Liu LF, Richardson JR, Li D, Bell D, Osei K, Jackson RD, Belury MA. Comparison of dietary conjugated linoleic acid with safflower oil on body composition in obese postmenopausal women with type 2 diabetes mellitus. A — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in plasma glucose AUC	significant change in plasma glucose AUC (0-3 h) from baseline to Week 16.	baseline and week 16	No
Secondary	change in insulin sensitivity		baseline and every 4 weeks until week 16	No
Secondary	change in glucose tolerance		baseline and every 4 weeks for 16 weeks	No
Secondary	change in HbA1c		baseline and week 16	No
Secondary	change in blood lipid profile		baseline and every 4 weeks for 16 weeks	No
Secondary	change in serum adipocytokines		baseline and every 4 weeks for 16 weeks	No
Secondary	change in hepatic enzymes		baseline and every 4 weeks for 16 weeks	Yes
Secondary	change in body composition		baseline and every 4 weeks for 16 weeks	No