Back to results

Development of Rational Ways of Medical and Non-medical Treatment Methods for Metabolic Syndrome (DRWMNTMS)

Primary Purpose

Metabolic Syndrome

Status

Completed

Phase

Phase 1

Locations

Kazakhstan

Study Type

Interventional

Intervention

Xenical, Pionorm, Diroton, Diltiazem, Atorvastatin

"Analimentary detoxication"

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Metabolic syndrome, Diabetes mellitus,, Hypertension, Overweight, analimentary detoxication

Eligibility Criteria

25 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Republican Scientific Center for Emergency Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

No Intervention

Arm Label

Conventional Patient group

"Analimentary detoxication" Weight loss

Healthy people

Arm Description

Xenical, Pionorm, Diroton, Diltiazem, Atorvastatin

Vegetables and salt diet

64 healthy people

Outcomes

Primary Outcome Measures

Blood Glucose Level

Fasting blood glucose (FBG) (mmole/L) and Two-hour postprandial glucose (THPG) (mmole/L) were measured.

Systolic/ Diastolic Blood Pressures (mm Hg)

Systolic and Diastolic Blood Pressures (mm Hg) was measured by manual/automatic tonometery

Secondary Outcome Measures

Lipid Profile

Blood sample for lipid profile (Cholesterol in mmole/L, High-density Lipoproteids in mmole/L, Triglycerides in mmole/L) was measured

Immunoassay Hormones in Blood

Immunoassay Insulin in the blood (in nU/L) was investigated

Immunoassay Cortisole in Blood

Immunoassay Cortisole in the blood (nmole/L) was measured

Full Information

NCT ID

NCT02503865

First Posted

April 10, 2015

Last Updated

November 2, 2015

Sponsor

Nazarbayev University

Collaborators

Institute Of Cardiology & Internal Diseases, Kazakhstan

1. Study Identification

Unique Protocol Identification Number

NCT02503865

Brief Title

Development of Rational Ways of Medical and Non-medical Treatment Methods for Metabolic Syndrome

Acronym

DRWMNTMS

Official Title

Phase 1-2 Study of Development of Rational Ways of Medical and Non-medical Treatment Methods for Metabolic Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

January 2003 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nazarbayev University

Collaborators

Institute Of Cardiology & Internal Diseases, Kazakhstan

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome

Keywords

Metabolic syndrome, Diabetes mellitus,, Hypertension, Overweight, analimentary detoxication

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

351 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Conventional Patient group

Arm Type

Active Comparator

Arm Description

Xenical, Pionorm, Diroton, Diltiazem, Atorvastatin

Arm Title

"Analimentary detoxication" Weight loss

Arm Type

Experimental

Arm Description

Vegetables and salt diet

Arm Title

Healthy people

Arm Type

No Intervention

Arm Description

64 healthy people

Intervention Type

Drug

Intervention Name(s)

Xenical, Pionorm, Diroton, Diltiazem, Atorvastatin

Other Intervention Name(s)

Conventional Patient group

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

"Analimentary detoxication"

Other Intervention Name(s)

Experimental Patient group

Intervention Description

Vegetable and salt diet

Primary Outcome Measure Information:

Title

Blood Glucose Level

Description

Fasting blood glucose (FBG) (mmole/L) and Two-hour postprandial glucose (THPG) (mmole/L) were measured.

Time Frame

up to 12 weeks

Title

Systolic/ Diastolic Blood Pressures (mm Hg)

Description

Systolic and Diastolic Blood Pressures (mm Hg) was measured by manual/automatic tonometery

Time Frame

up to 12 weeks

Secondary Outcome Measure Information:

Title

Lipid Profile

Description

Blood sample for lipid profile (Cholesterol in mmole/L, High-density Lipoproteids in mmole/L, Triglycerides in mmole/L) was measured

Time Frame

up to 12 weeks

Title

Immunoassay Hormones in Blood

Description

Immunoassay Insulin in the blood (in nU/L) was investigated

Time Frame

up to 12 weeks

Title

Immunoassay Cortisole in Blood

Description

Immunoassay Cortisole in the blood (nmole/L) was measured

Time Frame

up to 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

74 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tabynbayev Nariman, Professor

Organizational Affiliation

Nazarbayev University

Official's Role

Study Director

Facility Information:

Facility Name

Republican Scientific Center for Emergency Medicine

City

Astana

ZIP/Postal Code

010000

Country

Kazakhstan

12. IPD Sharing Statement

Citations:

PubMed Identifier

23451166

Citation

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.

Results Reference

background

PubMed Identifier

23176668

Citation

Berk 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 Reference

background

PubMed Identifier

22140269

Citation

Browning 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.

Results Reference

result

PubMed Identifier

28163748

Citation

Oshakbayev 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.

Results Reference

derived

Learn more about this trial

Development of Rational Ways of Medical and Non-medical Treatment Methods for Metabolic Syndrome

We'll reach out to this number within 24 hrs