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

Metabolic Syndrome Clinical Trial

— DRWMNTMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02503865
• Other study ID #: 0103RK00112
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 10, 2015
• Last updated: November 2, 2015
• Start date: January 2003
• Est. completion date: December 2014

Study information

• Verified date: November 2015
• Source: Republican Scientific Center for Emergency Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kazakhstan: Ethical CommissionKazakhstan: Ministry of Public Health
• Study type: Interventional

Clinical Trial Summary

Metabolic syndrome: aetiology, pathogenesis, diagnosis, clinical management and prognosis

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 351
• Est. completion date: December 2014
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 74 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Drug:
• Xenical, Pionorm, Diroton, Diltiazem, Atorvastatin
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

Dietary Supplement:
• "Analimentary detoxication"
Vegetable and salt diet

Locations

Country	Name	City	State
Kazakhstan	Republican Scientific Center for Emergency Medicine	Astana

Sponsors (2)

Lead Sponsor	Collaborator
Republican Scientific Center for Emergency Medicine	Institute Of Cardiology & Internal Diseases, Kazakhstan

Country where clinical trial is conducted

Kazakhstan, 

References & Publications (3)

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. — View 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):577-86. doi: 10.1194/jlr.P020867. Epub 2011 Dec 3. — View Citation

Penn L, White M, Lindström J, den Boer AT, Blaak E, Eriksson JG, Feskens E, Ilanne-Parikka P, Keinänen-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Glucose Level	Fasting blood glucose (FBG) (mmole/L) and Two-hour postprandial glucose (THPG) (mmole/L) were measured.	up to 12 weeks	Yes
Primary	Systolic/ Diastolic Blood Pressures (mm Hg)	Systolic and Diastolic Blood Pressures (mm Hg) was measured by manual/automatic tonometery	up to 12 weeks	Yes
Secondary	Lipid Profile	Blood sample for lipid profile (Cholesterol in mmole/L, High-density Lipoproteids in mmole/L, Triglycerides in mmole/L) was measured	up to 12 weeks	Yes
Secondary	Immunoassay Hormones in Blood	Immunoassay Insulin in the blood (in nU/L) was investigated	up to 12 weeks	Yes
Secondary	Immunoassay Cortisole in Blood	Immunoassay Cortisole in the blood (nmole/L) was measured	up to 12 weeks	Yes

External Links

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