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Type 2 Diabetes MellitusPhase 1FACTNCT00607945

Dietary Fatty Acids As Complementary Therapy in Type 2 Diabetes Mellitus

A Phase 1 study testing Rosiglitazone (Avandia) OR other diabetes medication currently prescribed to participant and conjugated linoleic acid (CLA) in people with Type 2 Diabetes Mellitus, run by Ohio State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 30 to 70 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Rosiglitazone (Avandia) OR other diabetes medication currently prescribed to participant and conjugated linoleic acid (CLA)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteUnited States
Study dates
Jan 2008to May 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Ohio State University Clinical Research Center (Davis Medical Research Center)

    Columbus, Ohio, 43210

Other trials in United States

About this study

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.

Read the 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.

Being tested
Rosiglitazone (Avandia) OR other diabetes medication currently prescribed to participant, conjugated linoleic acid (CLA)
Keywords
Type 2 diabetes mellitus, conjugated linoleic acid, weight loss, rosiglitazone, glucose control, insulin sensitivity
Medical subject headings
Diabetes Mellitus, Type 2, Weight Loss, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rosiglitazone (Avandia) OR other diabetes medication currently prescribed to participantDrug

    Also called Avandia

    Rosiglitazone 4-8mg/day, pill, from week -4 to week 32 OR other diabetes medication taken as prescribed from week -4 to week 32

  • conjugated linoleic acid (CLA)Dietary supplement

    Also called Tonalin, Clarinol

    3.2 g/day, capsule, week 0 to week 32

  • conjugated linoleic acid (CLA)Dietary supplement

    Also called Tonalin, Clarinol

    6.4 g/day, capsule, week 0 to week 32

Study groups in NCT00607945
Study groupRoleWhat they receive
0 g CLAPlacebo comparatorAvandia (Rosiglitazone) 4-8mg/day OR other diabetes medication currently prescribed to participant, 0 g CLA, 8 g Placebo oil (based on typical American diet)
Receives: Drug: Rosiglitazone (Avandia) OR other diabetes medication currently prescribed to participant
3.2 g CLAExperimentalAvandia 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)
Receives: Drug: Rosiglitazone (Avandia) OR other diabetes medication currently prescribed to participant; Dietary Supplement: conjugated linoleic acid (CLA)
6.4 g CLAExperimentalAvandia 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)
Receives: Drug: Rosiglitazone (Avandia) OR other diabetes medication currently prescribed to participant; Dietary Supplement: conjugated linoleic acid (CLA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference in change in body weight of the intervention groups

    Measured: Between baseline and week 32, or end of study

Secondary outcomes (18)

  1. Change in fat mass

    Measured: Between baseline and week 32

  2. Change in lean mass

    Measured: Between baseline and week 32

  3. Change in insulin sensitivity

    Measured: Between week 0 and week 32

  4. Change in lipid profile (TChol, LDL, HDL, C-reactive protein)

    Measured: Weeks -4, -1, 0, 8, 16, 24, 31, 32

  5. Changes in adipocytokine profile (leptin, adiponectin, visfatin, and resistin)

    Measured: Weeks -4, -1, 0, 8, 16, 24, 31, 32

  6. Changes in liver enzymes (ALT and AST)

    Measured: Weeks -4, -1, 0, 8, 16, 24, 31, 32

  7. Edema

    Measured: Weeks -4, -1, 0, 8, 16, 24, 31, 32

  8. Change in glucose control

    Measured: Weeks -1, 16, 31

  9. Change in bone density, bone formation and resorption markers

    Measured: Weeks -4, -1, 31

  10. Change in C-Peptide

    Measured: Weeks - 4, -1, 0, 1, 8, 16, 24, 31, 32

  11. Diabetes coping behaviors and self-efficacy

    Measured: Weeks -4, -1, 32

  12. Chronic stress (as measured by questionnaire)

    Measured: Weeks -4 and 32

  13. Appetite (as measured by appetite rating scale)

    Measured: Weeks -4, 0, 16, 32

  14. EKG

    Measured: Weeks -4, 16, 32

  15. BNP (brain type natriuretic peptide)

    Measured: Weeks -4 and 32

  16. Energy balance (physical activity recalls, food records, indirect calorimetry)

    Measured: Weeks -1, 16, 31

  17. Compliance (fatty acid composition, pill counts)

    Measured: Weeks -1, 0, 8, 16, 24, 31, 32

  18. Nutrition knowledge

    Measured: Weeks -4, 0, 32

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionMay 2012
  4. Study completionMay 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00607945
Sponsor's protocol ID
2007H0185
Other IDs
R21AT003520-01A2, 5R21AT003520
Acronym
FACT
Status last verified
Oct 2024
First submitted
24 Jan 2008
Last updated
29 Oct 2024
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Rosiglitazone (Avandia) OR other diabetes medication currently prescribed to participant and conjugated linoleic acid (CLA) in people with Type 2 Diabetes Mellitus, run by Ohio State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in change in body weight of the intervention groups (time frame: Between baseline and week 32, or end of study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00607945.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.

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