Supplementation With Conjugated Linoleic Acid (CLA) as Complementary Therapy in the Management of Type 2 Diabetes Mellitus (Women's Diabetes Study)
WDS
1 other identifier
interventional
55
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus
Started Dec 2004
Typical duration for not_applicable diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 10, 2010
CompletedFirst Posted
Study publicly available on registry
May 12, 2010
CompletedMay 12, 2010
May 1, 2010
1.9 years
May 10, 2010
May 10, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change in plasma glucose AUC
significant change in plasma glucose AUC (0-3 h) from baseline to Week 16.
baseline and week 16
Secondary Outcomes (7)
change in insulin sensitivity
baseline and every 4 weeks until week 16
change in glucose tolerance
baseline and every 4 weeks for 16 weeks
change in HbA1c
baseline and week 16
change in blood lipid profile
baseline and every 4 weeks for 16 weeks
change in serum adipocytokines
baseline and every 4 weeks for 16 weeks
- +2 more secondary outcomes
Study Arms (2)
Safflower Oil
PLACEBO COMPARATOR8.0 g/day safflower oil
CLA 6.4g/day
EXPERIMENTALConjugated linoleic acid at a dose of 6.4g/day in a supplement with a total of 8.0g oil
Interventions
6.4 g CLA/day, capsule form, for 16 week arms
Eligibility Criteria
You may qualify if:
- diagnosis of Type 2 diabetes mellitus
- obese
- postmenopausal
- HbA1c \>6.49 and \<14.1
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ohio State Universitylead
- Cogniscollaborator
Study Sites (1)
The Ohio State University
Columbus, Ohio, 43210, United States
Related 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. Am J Clin Nutr. 2009 Sep;90(3):468-76. doi: 10.3945/ajcn.2008.27371. Epub 2009 Jun 17.
PMID: 19535429RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martha A. Belury, PhD
Ohio State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 10, 2010
First Posted
May 12, 2010
Study Start
December 1, 2004
Primary Completion
November 1, 2006
Study Completion
November 1, 2006
Last Updated
May 12, 2010
Record last verified: 2010-05