Clinical trial NCT01121471: Supplementation With Conjugated Linoleic Acid (CLA) as Complementary Therapy in the Management of Type 2 Diabetes Mellitus (Women's Diabetes Study)
Official title: Supplementation With Conjugated Linoleic Acid (CLA) as Complementary Therapy in the Management of Type 2 Diabetes Mellitus (Women's Diabetes Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: diabetes
conjugated linoleic acid
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Cognis
First posted: 2010-05-12
Enrollment: 55
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

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 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

Primary outcomes:
measure: change in plasma glucose AUC
timeFrame: baseline and week 16
Secondary outcomes:
measure: change in insulin sensitivity
timeFrame: baseline and every 4 weeks until week 16
measure: change in glucose tolerance
timeFrame: baseline and every 4 weeks for 16 weeks
measure: change in HbA1c
timeFrame: baseline and week 16
measure: change in blood lipid profile
timeFrame: baseline and every 4 weeks for 16 weeks
measure: change in serum adipocytokines
timeFrame: baseline and every 4 weeks for 16 weeks
measure: change in hepatic enzymes
timeFrame: baseline and every 4 weeks for 16 weeks
measure: change in body composition
timeFrame: baseline and every 4 weeks for 16 weeks
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Martha A. Belury, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.