Dietary Fatty Acids As Complementary Therapy in Type 2 Diabetes Mellitus (FACT)
October 27, 2024 updated by: Martha Belury, Ohio State University
The purpose of the study is to see how a dietary oil called conjugated linoleic acid, or CLA, might be useful in combination with diabetes medication.
Some studies show that CLA can modestly reduce body weight and body fat.
Our research idea is that taking CLA will reduce body weight and body fat without interfering with the diabetes medications' effects on blood sugar.
Study Overview
Status
Completed
Conditions
Detailed Description
The long term goal of this research is to develop effective complementary strategies to aid in the management of type 2 diabetes (T2DM). Our central hypothesis is that CLA reduces body weight and body fat mass when administered concomitantly with oral diabetes medication, The rationale of this study is that using CLA to reduce body weight and body fat in people with T2DM may improve efficacy and longevity of the oral diabetes medications in the management of T2DM. We plan to test our central hypothesis and accomplish the overall objective of this research by pursuing the following three specific aims.
Specific Aim 1: Determine the ability of CLA to reduce body weight and body fat mass in people using oral diabetes medication for management of T2DM.
Specific Aim 2: Determine the ability of CLA to modulate insulin sensitivity when combined with oral diabetes medication.
Specific Aim 3: Determine the safety and tolerability of CLA in combination with oral diabetes medication.
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- The Ohio State University Clinical Research Center (Davis Medical Research Center)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Diagnosis of type 2 diabetes mellitus
- HbA1c ≤ 9%
- Overweight or obese (BMI ≥ 25 kg/m2 and ≤ 45 kg/m2)
- Age ≥ 30 and ≤ 70 years (postmenopausal if female)
- Stable medical therapy for past 3 months
- Stable body weight (within ± 2 kg) for past 3 months
- Plans to remain in the Columbus, OH metropolitan area for at least 1 year
Exclusion Criteria:
- Substance abuse
- Current use of prescription or over-the-counter medications or supplements known to affect body composition
- Current use of prescription or over-the-counter medications or supplements known to interact with thiazolidinediones(TZDs)
- Current or previous diagnosis of congestive heart failure
- Self-report of claustrophobia
- Abnormal liver function
- Impaired cognitive function
- Current or previous diagnosis of renal disease
- Gastrointestinal diseases or disorders
- Current use of hormone therapies, or use within the past 3 months
- Discontinuation of diabetes medication
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: 0 g CLA
Avandia (Rosiglitazone) 4-8mg/day OR other diabetes medication currently prescribed to participant, 0 g CLA, 8 g Placebo oil (based on typical American diet)
|
Rosiglitazone 4-8mg/day, pill, from week -4 to week 32 OR other diabetes medication taken as prescribed from week -4 to week 32
Other Names:
|
|
Experimental: 3.2 g CLA
Avandia 4-8mg/day OR other diabetes medication currently prescribed to participant, 3.2 g CLA, 4.8 g placebo oil (based on typical American diet)
|
Rosiglitazone 4-8mg/day, pill, from week -4 to week 32 OR other diabetes medication taken as prescribed from week -4 to week 32
Other Names:
3.2 g/day, capsule, week 0 to week 32
Other Names:
6.4 g/day, capsule, week 0 to week 32
Other Names:
|
|
Experimental: 6.4 g CLA
Avandia 4-8mg/day OR other diabetes medication currently prescribed to participant, 6.4 g CLA, 1.6 g placebo oil (based on typical American diet)
|
Rosiglitazone 4-8mg/day, pill, from week -4 to week 32 OR other diabetes medication taken as prescribed from week -4 to week 32
Other Names:
3.2 g/day, capsule, week 0 to week 32
Other Names:
6.4 g/day, capsule, week 0 to week 32
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Difference in change in body weight of the intervention groups
Time Frame: Between baseline and week 32, or end of study
|
Between baseline and week 32, or end of study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in fat mass
Time Frame: Between baseline and week 32
|
Between baseline and week 32
|
|
Change in lean mass
Time Frame: Between baseline and week 32
|
Between baseline and week 32
|
|
Change in insulin sensitivity
Time Frame: Between week 0 and week 32
|
Between week 0 and week 32
|
|
Change in lipid profile (TChol, LDL, HDL, C-reactive protein)
Time Frame: Weeks -4, -1, 0, 8, 16, 24, 31, 32
|
Weeks -4, -1, 0, 8, 16, 24, 31, 32
|
|
Changes in adipocytokine profile (leptin, adiponectin, visfatin, and resistin)
Time Frame: Weeks -4, -1, 0, 8, 16, 24, 31, 32
|
Weeks -4, -1, 0, 8, 16, 24, 31, 32
|
|
Changes in liver enzymes (ALT and AST)
Time Frame: Weeks -4, -1, 0, 8, 16, 24, 31, 32
|
Weeks -4, -1, 0, 8, 16, 24, 31, 32
|
|
Edema
Time Frame: Weeks -4, -1, 0, 8, 16, 24, 31, 32
|
Weeks -4, -1, 0, 8, 16, 24, 31, 32
|
|
Change in glucose control
Time Frame: Weeks -1, 16, 31
|
Weeks -1, 16, 31
|
|
Change in bone density, bone formation and resorption markers
Time Frame: Weeks -4, -1, 31
|
Weeks -4, -1, 31
|
|
Change in C-Peptide
Time Frame: Weeks - 4, -1, 0, 1, 8, 16, 24, 31, 32
|
Weeks - 4, -1, 0, 1, 8, 16, 24, 31, 32
|
|
Diabetes coping behaviors and self-efficacy
Time Frame: Weeks -4, -1, 32
|
Weeks -4, -1, 32
|
|
Chronic stress (as measured by questionnaire)
Time Frame: Weeks -4 and 32
|
Weeks -4 and 32
|
|
Appetite (as measured by appetite rating scale)
Time Frame: Weeks -4, 0, 16, 32
|
Weeks -4, 0, 16, 32
|
|
EKG
Time Frame: Weeks -4, 16, 32
|
Weeks -4, 16, 32
|
|
BNP (brain type natriuretic peptide)
Time Frame: Weeks -4 and 32
|
Weeks -4 and 32
|
|
Energy balance (physical activity recalls, food records, indirect calorimetry)
Time Frame: Weeks -1, 16, 31
|
Weeks -1, 16, 31
|
|
Compliance (fatty acid composition, pill counts)
Time Frame: Weeks -1, 0, 8, 16, 24, 31, 32
|
Weeks -1, 0, 8, 16, 24, 31, 32
|
|
Nutrition knowledge
Time Frame: Weeks -4, 0, 32
|
Weeks -4, 0, 32
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Martha A Belury, PhD, RD, Ohio State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
May 1, 2012
Study Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
January 24, 2008
First Submitted That Met QC Criteria
January 24, 2008
First Posted (Estimated)
February 6, 2008
Study Record Updates
Last Update Posted (Actual)
October 29, 2024
Last Update Submitted That Met QC Criteria
October 27, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2007H0185
- R21AT003520-01A2 (U.S. NIH Grant/Contract)
- 5R21AT003520 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.