Clinical trial NCT02503865: Development of Rational Ways of Medical and Non-medical Treatment Methods for Metabolic Syndrome
Official title: Phase 1-2 Study of Development of Rational Ways of Medical and Non-medical Treatment Methods for Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Metabolic Syndrome
Keywords: Metabolic syndrome
Diabetes mellitus,
Hypertension
Overweight
analimentary detoxication
Lead sponsor: Nazarbayev University
Sponsor class: OTHER
Collaborators: name: Institute Of Cardiology & Internal Diseases, Kazakhstan
First posted: 2015-07-21
Enrollment: 351
Sex: ALL
Minimum age (years): 25
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Blood Glucose Level
timeFrame: up to 12 weeks
measure: Systolic/ Diastolic Blood Pressures (mm Hg)
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Lipid Profile
timeFrame: up to 12 weeks
measure: Immunoassay Hormones in Blood
timeFrame: up to 12 weeks
measure: Immunoassay Cortisole in Blood
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Astana
country: Kazakhstan
facility: Republican Scientific Center for Emergency Medicine
Study officials:
affiliation: Nazarbayev University
name: Tabynbayev Nariman, Professor
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.