Expired Study
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Columbus, Ohio 43210


Purpose:

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 summary:

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.


Criteria:

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 is Available At:


Original ID:

2007H0185


NCT ID:

NCT00607945


Secondary ID:

R21AT003520-01A2


Study Acronym:

FACT


Brief Title:

Dietary Fatty Acids as Complementary Therapy in Type 2 Diabetes Mellitus


Official Title:

Dietary Fatty Acids as Complementary Therapy in Type 2 Diabetes Mellitus


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

30 Years


Maximum Age:

70 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Ohio State University


Oversight Authority:

  • United States: Federal Government
  • United States: Food and Drug Administration
  • United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

48


Enrollment Type:

Actual


Overall Contact Information

Official Name:Martha A Belury, PhD, RD
Principal Investigator
The Ohio State University Department of Human Nutrition

Study Dates

Start Date:January 2008
Completion Date:May 2012
Completion Type:Actual
Primary Completion Date:May 2012
Primary Completion Type:Actual
Verification Date:March 2014
Last Changed Date:March 19, 2014
First Received Date:January 24, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Nutrition knowledge
Time Frame:Weeks -4, 0, 32
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Compliance (fatty acid composition, pill counts)
Time Frame:Weeks -1, 0, 8, 16, 24, 31, 32
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Energy balance (physical activity recalls, food records, indirect calorimetry)
Time Frame:Weeks -1, 16, 31
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:BNP (brain type natriuretic peptide)
Time Frame:Weeks -4 and 32
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:EKG
Time Frame:Weeks -4, 16, 32
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Appetite (as measured by appetite rating scale)
Time Frame:Weeks -4, 0, 16, 32
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Chronic stress (as measured by questionnaire)
Time Frame:Weeks -4 and 32
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Diabetes coping behaviors and self-efficacy
Time Frame:Weeks -4, -1, 32
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in C-Peptide
Time Frame:Weeks - 4, -1, 0, 1, 8, 16, 24, 31, 32
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in bone density, bone formation and resorption markers
Time Frame:Weeks -4, -1, 31
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in glucose control
Time Frame:Weeks -1, 16, 31
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Edema
Time Frame:Weeks -4, -1, 0, 8, 16, 24, 31, 32
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Changes in liver enzymes (ALT and AST)
Time Frame:Weeks -4, -1, 0, 8, 16, 24, 31, 32
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Changes in adipocytokine profile (leptin, adiponectin, visfatin, and resistin)
Time Frame:Weeks -4, -1, 0, 8, 16, 24, 31, 32
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in lipid profile (TChol, LDL, HDL, C-reactive protein)
Time Frame:Weeks -4, -1, 0, 8, 16, 24, 31, 32
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Change in insulin sensitivity
Time Frame:Between week 0 and week 32
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in lean mass
Time Frame:Between baseline and week 32
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in fat mass
Time Frame:Between baseline and week 32
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Difference in change in body weight of the intervention groups
Time Frame:Between baseline and week 32, or end of study
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Rosiglitazone (Avandia) OR other diabetes medicati
Description:Rosiglitazone 4-8mg/day, pill, from week -4 to week 32 OR other diabetes medication taken as prescribed from week -4 to week 32
Arm Name:0 g CLA
Other Name:Avandia
Intervention Type:Dietary Supplement
Name:conjugated linoleic acid (CLA)
Description:3.2 g/day, capsule, week 0 to week 32
Arm Name:3.2 g CLA
Other Name:Tonalin, Clarinol
Intervention Type:Dietary Supplement
Name:conjugated linoleic acid (CLA)
Description:6.4 g/day, capsule, week 0 to week 32
Arm Name:6.4 g CLA
Other Name:Tonalin, Clarinol

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:0 g CLA
Description: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)
Study Arm Type:Experimental
Arm Name:3.2 g CLA
Description: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)
Study Arm Type:Experimental
Arm Name:6.4 g CLA
Description: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)

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Ohio State University
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Center for Complementary and Alternative Medicine (NCCAM)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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