Metabolic SyndromePhase 1/2DRWMNTMSNCT02503865
Development of Rational Ways of Medical and Non-medical Treatment Methods for Metabolic Syndrome
A Phase 1/2 study testing Xenical, Pionorm, Diroton, Diltiazem, Atorvastatin and "Analimentary detoxication" in people with Metabolic Syndrome, run by Nazarbayev University at 1 site in Kazakhstan.
Trial summary
Metabolic syndrome: aetiology, pathogenesis, diagnosis, clinical management and prognosis Read more about this study
- Who is it for?
- Ages 25 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Xenical, Pionorm, Diroton, Diltiazem, Atorvastatin and "Analimentary detoxication"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 351 participants
- Where
- 1 siteKazakhstan
- Study dates
- Jan 2003to Dec 2014
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- written consent form
- age> 25 years
- skinfold thickness > 0,7 cm BP> 130/85 mm Hg or a patient on antihypertensive medications fasting blood glucose > 6.1 mmole/L, or 2-hour postprandial glucose level > 11.1 mmole/L / or a patient with type 2 diabetes blood cholesterol > 5.6 mmole/L possibility of treatment > 6 months follow-up > 1 year
Who cannot join
- complete immobilization of a patient (paresis /paralysis)
- patients with severe concomitant diseases of the kidneys and (or) of the liver
- early post-operative condition
- mental illness
- pregnancy
- persons who are in prison
- persons who are in military Armed Forces
Trial locations and contacts
1 site in 1 country.
Kazakhstan1 site
Republican Scientific Center for Emergency Medicine
Astana, Astana, 010000
About this study
Official title: Phase 1-2 Study of Development of Rational Ways of Medical and Non-medical Treatment Methods for Metabolic Syndrome
Metabolic syndrome: aetiology, pathogenesis, diagnosis, clinical management and prognosis
Read the detailed description
Purpose: To create the complex scientifically proved concept of Metabolic syndrome (МS) development based on elaboration of the new methods of clinical diagnostics of МS components and highly effective МS clinical management in comparative studying of clinical, laboratory and cost effectiveness.
Participants and methods: This clinical study included 351 adults (184 female) in the Scientific research institute of cardiology and internal diseases (Almaty, the Republic of Kazakhstan). Statistical analysis was performed using Microsoft Excel-2008 in updating Lapach, Chubenko et al (2000) and SPSS for Windows v.17.0.
- Conditions
- Metabolic Syndrome
- Being tested
- Xenical, Pionorm, Diroton, Diltiazem, Atorvastatin, "Analimentary detoxication"
- Keywords
- Metabolic syndrome, Diabetes mellitus,, Hypertension, Overweight, analimentary detoxication
- Medical subject headings
- Metabolic Syndrome, Diabetes Mellitus, Hypertension, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xenical, Pionorm, Diroton, Diltiazem, AtorvastatinDrug
Also called Conventional Patient group
Xenical (Orlistat) - 120 mg/day in integration of Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day
"Analimentary detoxication"Dietary supplement
Also called Experimental Patient group
Vegetable and salt diet
| Study group | Role | What they receive |
|---|---|---|
| Conventional Patient group | Active comparator | Xenical, Pionorm, Diroton, Diltiazem, Atorvastatin Receives: Drug: Xenical, Pionorm, Diroton, Diltiazem, Atorvastatin |
| "Analimentary detoxication" Weight loss | Experimental | Vegetables and salt diet Receives: Dietary Supplement: "Analimentary detoxication" |
| Healthy people | No intervention | 64 healthy people |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose Level
Fasting blood glucose (FBG) (mmole/L) and Two-hour postprandial glucose (THPG) (mmole/L) were measured.
Measured: up to 12 weeks
Systolic/ Diastolic Blood Pressures (mm Hg)
Systolic and Diastolic Blood Pressures (mm Hg) was measured by manual/automatic tonometery
Measured: up to 12 weeks
Secondary outcomes (3)
Lipid Profile
Blood sample for lipid profile (Cholesterol in mmole/L, High-density Lipoproteids in mmole/L, Triglycerides in mmole/L) was measured
Measured: up to 12 weeks
Immunoassay Hormones in Blood
Immunoassay Insulin in the blood (in nU/L) was investigated
Measured: up to 12 weeks
Immunoassay Cortisole in Blood
Immunoassay Cortisole in the blood (nmole/L) was measured
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study startJan 2003
- Primary completionDec 2008
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nazarbayev University
- Sponsor type
- University, hospital or other
- Collaborators
- Institute Of Cardiology & Internal Diseases, Kazakhstan
- Responsible party
- Principal investigator, Kuat Oshakbayev, Nazarbayev University
- Investigators
- Tabynbayev Nariman, Professor, Study director, Nazarbayev University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503865
- Sponsor's protocol ID
- 0103RK00112
- Acronym
- DRWMNTMS
- Status last verified
- Nov 2015
- First submitted
- 10 Apr 2015
- Last updated
- 30 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Penn L, White M, Lindstrom J, den Boer AT, Blaak E, Eriksson JG, Feskens E, Ilanne-Parikka P, Keinanen-Kiukaanniemi SM, Walker M, Mathers JC, Uusitupa M, Tuomilehto J. Importance of weight loss maintenance and risk prediction in the prevention of type 2 diabetes: analysis of European Diabetes Prevention Study RCT. PLoS One. 2013;8(2):e57143. doi: 10.1371/journal.pone.0057143. Epub 2013 Feb 25.
PubMed 23451166Berk KA, Buijks H, Ozcan B, Van't Spijker A, Busschbach JJ, Sijbrands EJ. The Prevention Of WEight Regain in diabetes type 2 (POWER) study: the effectiveness of adding a combined psychological intervention to a very low calorie diet, design and pilot data of a randomized controlled trial. BMC Public Health. 2012 Nov 23;12:1026. doi: 10.1186/1471-2458-12-1026.
PubMed 23176668Browning JD, Baxter J, Satapati S, Burgess SC. The effect of short-term fasting on liver and skeletal muscle lipid, glucose, and energy metabolism in healthy women and men. J Lipid Res. 2012 Mar;53(3):577-586. doi: 10.1194/jlr.P020867. Epub 2011 Dec 3.
PubMed 22140269Oshakbayev K, Dukenbayeva B, Togizbayeva G, Durmanova A, Gazaliyeva M, Sabir A, Issa A, Idrisov A. Weight loss technology for people with treated type 2 diabetes: a randomized controlled trial. Nutr Metab (Lond). 2017 Jan 31;14:11. doi: 10.1186/s12986-017-0163-9. eCollection 2017.
PubMed 28163748
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1-2 Study of Development of Rational Ways of Medical and Non-medical Treatment Methods for Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT02503865
- Acronym / sponsor ID
- DRWMNTMS / 0103RK00112
- Conditions
- Metabolic Syndrome
- Keywords
- Metabolic syndrome, Diabetes mellitus,, Hypertension, Overweight, analimentary detoxication
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 351 participants (actual)
- Lead sponsor
- Nazarbayev UniversityUniversity, hospital or other
- Collaborators
- Institute Of Cardiology & Internal Diseases, Kazakhstan
- Study start
- Jan 2003
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 Jul 2015 (estimated)
- Results
- Posted 3 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Metabolic syndrome: aetiology, pathogenesis, diagnosis, clinical management and prognosis
Detailed description
Purpose: To create the complex scientifically proved concept of Metabolic syndrome (МS) development based on elaboration of the new methods of clinical diagnostics of МS components and highly effective МS clinical management in comparative studying of clinical, laboratory and cost effectiveness.
Participants and methods: This clinical study included 351 adults (184 female) in the Scientific research institute of cardiology and internal diseases (Almaty, the Republic of Kazakhstan). Statistical analysis was performed using Microsoft Excel-2008 in updating Lapach, Chubenko et al (2000) and SPSS for Windows v.17.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional Patient group | Active comparator | Drug: Xenical, Pionorm, Diroton, Diltiazem, AtorvastatinXenical, Pionorm, Diroton, Diltiazem, Atorvastatin |
| "Analimentary detoxication" Weight loss | Experimental | Dietary Supplement: "Analimentary detoxication"Vegetables and salt diet |
| Healthy people | No intervention | –64 healthy people |
Who may qualify
- Ages
- 25 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- written consent form
- age> 25 years
- skinfold thickness > 0,7 cm BP> 130/85 mm Hg or a patient on antihypertensive medications fasting blood glucose > 6.1 mmole/L, or 2-hour postprandial glucose level > 11.1 mmole/L / or a patient with type 2 diabetes blood cholesterol > 5.6 mmole/L possibility of treatment > 6 months follow-up > 1 year
Key exclusion criteria (7 listed)
- complete immobilization of a patient (paresis /paralysis)
- patients with severe concomitant diseases of the kidneys and (or) of the liver
- early post-operative condition
- mental illness
- pregnancy
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 |
|---|---|---|
| Xenical, Pionorm, Diroton, Diltiazem, AtorvastatinAlso: Conventional Patient groupXenical (Orlistat) - 120 mg/day in integration of Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day | Drug | Conventional Patient group |
| "Analimentary detoxication"Also: Experimental Patient groupVegetable and salt diet | Dietary supplement | "Analimentary detoxication" Weight loss |
Primary outcome
Blood Glucose Level
Time frame: up to 12 weeks
Fasting blood glucose (FBG) (mmole/L) and Two-hour postprandial glucose (THPG) (mmole/L) were measured.
Systolic/ Diastolic Blood Pressures (mm Hg)
Time frame: up to 12 weeks
Systolic and Diastolic Blood Pressures (mm Hg) was measured by manual/automatic tonometery
3 secondary outcomes
Lipid Profile
Time frame: up to 12 weeks
Immunoassay Hormones in Blood
Time frame: up to 12 weeks
Immunoassay Cortisole in Blood
Time frame: up to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23451166Penn L, White M, Lindstrom J, den Boer AT, Blaak E, Eriksson JG, Feskens E, Ilanne-Parikka P, Keinanen-Kiukaanniemi SM, Walker M, Mathers JC, Uusitupa M, Tuomilehto J. Importance of weight loss maintenance and risk prediction in the prevention of type 2 diabetes: analysis of European Diabetes Prevention Study RCT. PLoS One. 2013;8(2):e57143. doi: 10.1371/journal.pone.0057143. Epub 2013 Feb 25.
- Background: PubMed 23176668Berk KA, Buijks H, Ozcan B, Van't Spijker A, Busschbach JJ, Sijbrands EJ. The Prevention Of WEight Regain in diabetes type 2 (POWER) study: the effectiveness of adding a combined psychological intervention to a very low calorie diet, design and pilot data of a randomized controlled trial. BMC Public Health. 2012 Nov 23;12:1026. doi: 10.1186/1471-2458-12-1026.
- Results publication: PubMed 22140269Browning JD, Baxter J, Satapati S, Burgess SC. The effect of short-term fasting on liver and skeletal muscle lipid, glucose, and energy metabolism in healthy women and men. J Lipid Res. 2012 Mar;53(3):577-586. doi: 10.1194/jlr.P020867. Epub 2011 Dec 3.
- Derived from this study: PubMed 28163748Oshakbayev K, Dukenbayeva B, Togizbayeva G, Durmanova A, Gazaliyeva M, Sabir A, Issa A, Idrisov A. Weight loss technology for people with treated type 2 diabetes: a randomized controlled trial. Nutr Metab (Lond). 2017 Jan 31;14:11. doi: 10.1186/s12986-017-0163-9. eCollection 2017.
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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.
Tabynbayev Nariman, Professor study director
Nazarbayev University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Xenical, Pionorm, Diroton, Diltiazem, Atorvastatin and "Analimentary detoxication" in people with Metabolic Syndrome, run by Nazarbayev University at 1 site in Kazakhstan.
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 3 inclusion and 7 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 30 Nov 2015. 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 Kazakhstan. 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.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Glucose Level (time frame: up to 12 weeks). The study lists 2 primary outcomes in all. 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 NCT02503865, which also lists 4 linked publications.
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 30 Nov 2015.