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

NCT02503865 | Completed Phase 1 Results DMC

• 1 other identifier: 0103RK00112
• Study Type: interventional
• Target: 351
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metabolic Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Blood Glucose Level

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

  up to 12 weeks

• Systolic/ Diastolic Blood Pressures (mm Hg)

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

  up to 12 weeks

Secondary Outcomes (3)

• Lipid Profile

  up to 12 weeks

• Immunoassay Hormones in Blood

  up to 12 weeks

• Immunoassay Cortisole in Blood

  up to 12 weeks

Study Arms (3)

Conventional Patient group

ACTIVE COMPARATOR

Xenical, Pionorm, Diroton, Diltiazem, Atorvastatin

Drug: Xenical, Pionorm, Diroton, Diltiazem, Atorvastatin

"Analimentary detoxication" Weight loss

EXPERIMENTAL

Vegetables and salt diet

Dietary Supplement: "Analimentary detoxication"

Healthy people

NO INTERVENTION

64 healthy people

Interventions

Xenical, Pionorm, Diroton, Diltiazem, Atorvastatin DRUG

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

Also known as: Conventional Patient group

Conventional Patient group

"Analimentary detoxication" DIETARY_SUPPLEMENT

Vegetable and salt diet

Also known as: Experimental Patient group

"Analimentary detoxication" Weight loss

Eligibility Criteria

• Age: 25 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nazarbayev University: lead
• Institute Of Cardiology & Internal Diseases, Kazakhstan: collaborator

Study Sites (1)

Republican Scientific Center for Emergency Medicine

Astana, Astana, 010000, Kazakhstan

Location

Related Publications (4)

• 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.

  PMID: 23451166 BACKGROUND

• 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.

  PMID: 23176668 BACKGROUND

• 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.

  PMID: 22140269 RESULT

• 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.

  PMID: 28163748 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Diabetes Mellitus; Hypertension; Overweight

Interventions

Orlistat; Diltiazem; Atorvastatin

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heptanoic Acids; Fatty Acids; Lipids

Limitations and Caveats

We acknowledge the randomized clinical trial have not a large sample size

Results Point of Contact

• Title: Dr. Kuat Oshakbayev
• Organization: Republican Scientific Center for Emergency care at Nazarbayev University

okp.kuat@mail.ru

+77013999141

Study Officials

• Tabynbayev Nariman, Professor

  Nazarbayev University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary investigator

Study Record Dates

• First Submitted: April 10, 2015
• First Posted: July 21, 2015
• Study Start: January 1, 2003
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2014
• Last Updated: November 30, 2015
• Results First Posted: November 3, 2015

Record last verified: 2015-11

Locations

KA (1)