Type 2 Diabetes MellitusNCT01099163
Effect of Conjugated Linoleic Acid Alone and in Conjunction With Vitamin E in Patients With Type 2 Diabetes Mellitus
A study testing Tonalin SG1000T FFA in people with Type 2 Diabetes Mellitus, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
Conjugated linoleic acids (CLAs) comprise a family of linoleic acid (18:2n-6; LA) isomers that are formed by biohydrogenation and oxidation processes in nature. The main form of CLA, cis-9, trans-11-18:2, can be produced directly by bacterial hydrogenation in the rumen or by delta-9 desaturation of the co-product… 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?
- Tonalin SG1000T FFA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- Jan 2009to Oct 2010
- Phase
- Interventional
- 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 > 5 years
- HbA1c ≤ 9%
- Overweight or obese (BMI ≥ 25 kg/m2 and ≤ 30 kg/m2)
- Age ≥ 30 and ≤ 70 years (postmenopausal if female)
- Stable medical therapy for past 3 months
- Stable serum glucose for past 3 months (128-180 mg/Dl)
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- Age between 30 to 50
- Use of metformin
- TG < 240 mg/Dl
- No alcohol, no insulin, no smoke
- No pregnancy, no menopause
Who cannot join
- Personal history of coronary heart disease
- Cerebrovascular disease or vascular disease
- Renal or hepatic disease
- Inflammatory diseases and thyroid diseases within the last years
- Use of drugs known to affect glycemic control, beta blockers, any change in daily activity profile, and diet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Conjugated Linoleic Acid Alone and in Conjunction With Vitamin E on Insulin Sensitivity, Beta Cell Function, Markers of Inflammation, Body Fat Mass and Other Biochemical Indicators in Patients With Type 2 Diabetes Mellitus
Conjugated linoleic acids (CLAs) comprise a family of linoleic acid (18:2n-6; LA) isomers that are formed by biohydrogenation and oxidation processes in nature. The main form of CLA, cis-9, trans-11-18:2, can be produced directly by bacterial hydrogenation in the rumen or by delta-9 desaturation of the co-product vaccenic acid (trans-11-18:1) in most mammalian tissues including man. The second most abundant isomer of CLA is the trans-10, cis-12-18:2 form. Observations clearly emphasize that differences exist between mammalian species in their response to CLAs with mice being the most sensitive. The majority of studies on body compositional effects (i.e. fat loss, lean gain), on cancer and cardiovascular disease attenuation, on insulin sensitivity and diabetes and on immune function have been conducted with a variety of animal models. Recent studies indicate that some but not all of the effects observed in animals also pertain to human volunteers. Reports of detrimental effects of CLA intake appear to be largely in mice and due mainly to the trans-10, cis-12 isomer. Suggestions of possible deleterious effects in man due to an increase in oxidative lipid products (isoprostanes) with trans-10, cis-12 CLA ingestion require substantiation. Unresponsiveness to antioxidants of these non-enzymatic oxidation products casts some doubt on their physiological relevance. We hypothesized that supplementation with CLA + an antioxidant (vitamin E) in patients with diabetes mellitus may have beneficial effects on glycemic control and insulin sensitivity.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Tonalin SG1000T FFA
- Keywords
- Diabetes mellitus, CLA, Antioxidant, Glycemic control
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tonalin SG1000T FFADietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 3g CLA | Experimental | 3 g CLA (50:50%) AND other diabetes medication currently prescribed to participant, 100 IU vitamin E Receives: Dietary Supplement: Tonalin SG1000T FFA |
| 3 g CLA | Active comparator | 3 g CLA (50:50%) AND other diabetes medication currently prescribed to participant, vitamin E placebo Receives: Dietary Supplement: Tonalin SG1000T FFA |
| 3 g MCT + vit E placebo | No intervention | 3 g MCT AND other diabetes medication currently prescribed to participant, 100 IU vitamin E placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin sensitivity
beta cell function
glycosylated hemoglobin
Secondary outcomes (6)
inflammatory mediators (TNF-alpha, Il-1beta, Il-6, CRP, adiponectin, leptin)
systolic and diastolic blood pressure
serum lipids (TG, LDL, HDL, LDL/HDL, ApoB100)
fibrinogen, PAI-1
body fat using bioimpedance
oxidative stress (MDA)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2010 (estimated)
- Study startJan 2009
- Primary completionMar 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01099163
- Sponsor's protocol ID
- 2387
- Status last verified
- Apr 2010
- First submitted
- 5 Apr 2010
- Last updated
- 15 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Conjugated Linoleic Acid Alone and in Conjunction With Vitamin E on Insulin Sensitivity, Beta Cell Function, Markers of Inflammation, Body Fat Mass and Other Biochemical Indicators in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01099163
- Acronym / sponsor ID
- 2387
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Diabetes mellitus, CLA, Antioxidant, Glycemic control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 6 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Conjugated linoleic acids (CLAs) comprise a family of linoleic acid (18:2n-6; LA) isomers that are formed by biohydrogenation and oxidation processes in nature. The main form of CLA, cis-9, trans-11-18:2, can be produced directly by bacterial hydrogenation in the rumen or by delta-9 desaturation of the co-product vaccenic acid (trans-11-18:1) in most mammalian tissues including man. The second most abundant isomer of CLA is the trans-10, cis-12-18:2 form. Observations clearly emphasize that differences exist between mammalian species in their response to CLAs with mice being the most sensitive. The majority of studies on body compositional effects (i.e. fat loss, lean gain), on cancer and cardiovascular disease attenuation, on insulin sensitivity and diabetes and on immune function have been conducted with a variety of animal models. Recent studies indicate that some but not all of the effects observed in animals also pertain to human volunteers. Reports of detrimental effects of CLA intake appear to be largely in mice and due mainly to the trans-10, cis-12 isomer. Suggestions of possible deleterious effects in man due to an increase in oxidative lipid products (isoprostanes) with trans-10, cis-12 CLA ingestion require substantiation. Unresponsiveness to antioxidants of these non-enzymatic oxidation products casts some doubt on their physiological relevance. We hypothesized that supplementation with CLA + an antioxidant (vitamin E) in patients with diabetes mellitus may have beneficial effects on glycemic control and insulin sensitivity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3g CLA | Experimental | Dietary Supplement: Tonalin SG1000T FFA3 g CLA (50:50%) AND other diabetes medication currently prescribed to participant, 100 IU vitamin E |
| 3 g CLA | Active comparator | Dietary Supplement: Tonalin SG1000T FFA3 g CLA (50:50%) AND other diabetes medication currently prescribed to participant, vitamin E placebo |
| 3 g MCT + vit E placebo | No intervention | –3 g MCT AND other diabetes medication currently prescribed to participant, 100 IU vitamin E placebo |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosis of type 2 diabetes mellitus > 5 years
- HbA1c ≤ 9%
- Overweight or obese (BMI ≥ 25 kg/m2 and ≤ 30 kg/m2)
- Age ≥ 30 and ≤ 70 years (postmenopausal if female)
- Stable medical therapy for past 3 months
Key exclusion criteria (5 listed)
- Personal history of coronary heart disease
- Cerebrovascular disease or vascular disease
- Renal or hepatic disease
- Inflammatory diseases and thyroid diseases within the last years
- Use of drugs known to affect glycemic control, beta blockers, any change in daily activity profile, and diet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tonalin SG1000T FFA | Dietary supplement | 3 g CLA, 3g CLA |
Primary outcome
insulin sensitivity
beta cell function
glycosylated hemoglobin
6 secondary outcomes
inflammatory mediators (TNF-alpha, Il-1beta, Il-6, CRP, adiponectin, leptin)
systolic and diastolic blood pressure
serum lipids (TG, LDL, HDL, LDL/HDL, ApoB100)
fibrinogen, PAI-1
body fat using bioimpedance
oxidative stress (MDA)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tonalin SG1000T FFA in people with Type 2 Diabetes Mellitus, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 11 inclusion and 5 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 15 Jun 2011. 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 Iran. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
insulin sensitivity. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2011.