Metabolic SyndromePhase 3NCT01025115
Diamel in the Treatment of Metabolic Syndrome
A Phase 3 study testing Diamel in people with Metabolic Syndrome, run by Catalysis SL at 1 site in Cuba.
Trial summary
The purpose of this study is to assess the efficacy of Diamel administration in the treatment of Metabolic Syndrome. The duration of this double-blind placebo controlled phase 3 clinical trial will be 12 months. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Diamel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteCuba
- Study dates
- Mar 2009to Mar 2010
- Phase
- Phase 3
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Metabolic syndrome diagnosis according to WHO definition, with or without glucose intolerance.
- Signed informed consent
Who cannot join
- Type 1 diabetes
- Type 2 diabetes treated with oral hypoglycemic drugs and/or insulin
- Other diseases associated with insulin resistance (eg. Acromegalia, endogenous hypercortisolism, etc)
- Neuropathies or hepatic conditions diagnosed biochemically or by clinical exam.
- Mild or severe heart conditions (eg. heart failure, ischemic cardiopathy)
- Sepsis or any other condition that could potentially interfere with treatment
- Any other treatment that could potentially interfere with treatment
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Diamel in the Treatment of Metabolic Syndrome
The purpose of this study is to assess the efficacy of Diamel administration in the treatment of Metabolic Syndrome. The duration of this double-blind placebo controlled phase 3 clinical trial will be 12 months.
- Conditions
- Metabolic Syndrome
- Being tested
- Diamel, Placebo
- Keywords
- Dietary supplement, Diamel, Metabolic Syndrome
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiamelDietary supplement
Two Diamel tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 12 months, together with the standard treatment for metabolic syndrome consisting in appropriate diet according to patient's weight and physical activity, and appropriate hypertensive drugs (generally ACE inhibitors) for hypertension. Patient´s were also verbally encouraged to increase physical activity (to walk for 30-45 minutes a day 3-4 days a week).
PlaceboDietary supplement
Two Placebo tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 12 months, together with the standard treatment for metabolic syndrome consisting in appropriate diet according to patient's weight and physical activity, and appropriate hypertensive drugs (generally ACE inhibitors) for hypertension. Patient´s were also verbally encouraged to increase physical activity (to walk for 30-45 minutes a day 3-4 days a week).
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Diamel Receives: Dietary Supplement: Diamel |
| B | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood concentrations of glucose at months 0,3,6,9,12.
Measured: 12 months
Blood concentrations of insulin at months 0,3,6,9,12.
Measured: 12 months
Blood concentrations of cholesterol at months 0,3,6,9,12.
Measured: 12 months
Blood concentrations of HDL-cholesterol at months 0,3,6,9,12.
Measured: 12 months
Blood concentrations of triglycerides at months 0,3,6,9,12.
Measured: 12 months
Blood concentrations of creatinine at months 0,3,6,9,12.
Measured: 12 months
Blood concentrations of uric acid at months 0,3,6,9,12.
Measured: 12 months
Secondary outcomes (3)
Blood pressure at months 0,3,6,9,12.
Measured: 12 months
BMI index at months 0,3,6,9,12.
Measured: 12 months
Waist-to-hip index at months 0,3,6,9,12.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catalysis SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eduardo Cabrera-Rode, PhD, Principal investigator, National Institute of Endocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01025115
- Sponsor's protocol ID
- CAT-0918-CU
- Status last verified
- Mar 2010
- First submitted
- 2 Dec 2009
- Last updated
- 31 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Diamel in the Treatment of Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT01025115
- Acronym / sponsor ID
- CAT-0918-CU
- Conditions
- Metabolic Syndrome
- Keywords
- Dietary supplement, Diamel, Metabolic Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Catalysis SLIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 3 Dec 2009 (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.
The purpose of this study is to assess the efficacy of Diamel administration in the treatment of Metabolic Syndrome. The duration of this double-blind placebo controlled phase 3 clinical trial will be 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Dietary Supplement: DiamelDiamel |
| B | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Metabolic syndrome diagnosis according to WHO definition, with or without glucose intolerance.
- Signed informed consent
Key exclusion criteria (8 listed)
- Type 1 diabetes
- Type 2 diabetes treated with oral hypoglycemic drugs and/or insulin
- Other diseases associated with insulin resistance (eg. Acromegalia, endogenous hypercortisolism, etc)
- Neuropathies or hepatic conditions diagnosed biochemically or by clinical exam.
- Mild or severe heart conditions (eg. heart failure, ischemic cardiopathy)
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 |
|---|---|---|
| DiamelTwo Diamel tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 12 months, together with the standard treatment for metabolic syndrome consisting in appropriate diet according to patient's weight and physical activity, and appropriate hypertensive drugs (generally ACE inhibitors) for hypertension. Patient´s were also verbally encouraged to increase physical activity (to walk for 30-45 minutes a day 3-4 days a week). | Dietary supplement | A |
| PlaceboTwo Placebo tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 12 months, together with the standard treatment for metabolic syndrome consisting in appropriate diet according to patient's weight and physical activity, and appropriate hypertensive drugs (generally ACE inhibitors) for hypertension. Patient´s were also verbally encouraged to increase physical activity (to walk for 30-45 minutes a day 3-4 days a week). | Dietary supplement | B |
Primary outcome
Blood concentrations of glucose at months 0,3,6,9,12.
Time frame: 12 months
Blood concentrations of insulin at months 0,3,6,9,12.
Time frame: 12 months
Blood concentrations of cholesterol at months 0,3,6,9,12.
Time frame: 12 months
Blood concentrations of HDL-cholesterol at months 0,3,6,9,12.
Time frame: 12 months
Blood concentrations of triglycerides at months 0,3,6,9,12.
Time frame: 12 months
Blood concentrations of creatinine at months 0,3,6,9,12.
Time frame: 12 months
Blood concentrations of uric acid at months 0,3,6,9,12.
Time frame: 12 months
3 secondary outcomes
Blood pressure at months 0,3,6,9,12.
Time frame: 12 months
BMI index at months 0,3,6,9,12.
Time frame: 12 months
Waist-to-hip index at months 0,3,6,9,12.
Time frame: 12 months
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 31 Mar 2010.
Related trials for Metabolic Syndrome
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
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.
Eduardo Cabrera-Rode, PhD principal investigator
National Institute of Endocrinology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Diamel in people with Metabolic Syndrome, run by Catalysis SL at 1 site in Cuba.
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 2 inclusion and 8 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 31 Mar 2010. 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 Cuba. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Blood concentrations of glucose at months 0,3,6,9,12. (time frame: 12 months). The study lists 7 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 31 Mar 2010.