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

• Sponsor: Nazarbayev University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02503865
• Collaborator: Institute Of Cardiology & Internal Diseases, Kazakhstan (Other)
• Enrollment: 351
• Location: 1
• Arms: 3
• Duration (Months): 143
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome	Drug: Xenical, Pionorm, Diroton, Diltiazem, Atorvastatin; Dietary Supplement: "Analimentary detoxication"	Phase 1/Phase 2

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

• Study Type: Interventional
• Actual Enrollment: 351 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 1-2 Study of Development of Rational Ways of Medical and Non-medical Treatment Methods for Metabolic Syndrome
• Study Start Date: Jan 1, 2003
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Conventional Patient group Xenical, Pionorm, Diroton, Diltiazem, Atorvastatin	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; Other Names: Conventional Patient group
Experimental: "Analimentary detoxication" Weight loss Vegetables and salt diet	Dietary Supplement: "Analimentary detoxication"; Vegetable and salt diet; Other Names: Experimental Patient group
No Intervention: Healthy people 64 healthy people

Outcome Measures

Primary Outcome Measures

1. Blood Glucose Level [up to 12 weeks]

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

2. Systolic/ Diastolic Blood Pressures (mm Hg) [up to 12 weeks]

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

Secondary Outcome Measures

1. Lipid Profile [up to 12 weeks]

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

2. Immunoassay Hormones in Blood [up to 12 weeks]

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

3. Immunoassay Cortisole in Blood [up to 12 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 74 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Republican Scientific Center for Emergency Medicine	Astana		Kazakhstan	010000

Sponsors and Collaborators

• Nazarbayev University
• Institute Of Cardiology & Internal Diseases, Kazakhstan

Investigators

• Study Director: Tabynbayev Nariman, Professor, Nazarbayev University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Click here for more information about this study: Learn how to lose weight in a healthy way and keep it off. Find the weight loss strategy that works best for you and start feeling better now.

Publications

• 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.
• 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.

• Responsible Party: Kuat Oshakbayev, Primary investigator, Nazarbayev University
• ClinicalTrials.gov Identifier: NCT02503865
• Other Study ID Numbers: 0103RK00112
• First Posted: Jul 21, 2015
• Last Update Posted: Nov 30, 2015
• Last Verified: Nov 1, 2015

• Keywords provided by Kuat Oshakbayev, Primary investigator, Nazarbayev University: Metabolic syndrome; Diabetes mellitus,; Hypertension; Overweight; analimentary detoxication
• Additional relevant MeSH terms: Metabolic Syndrome; Syndrome; Orlistat; Diltiazem; Atorvastatin

Study Results

Participant Flow

Arm/Group Title	Conventional Patient Group	"Analimentary Detoxication"	Healthy People
Arm/Group Description	Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day	Dietary Supplement - Vegetable and salt diet. Weight loss program "Analimentary detoxication" "Analimentary detoxication": Vegetable and salt diet	64 healthy people
Period Title: Overall Study
STARTED	70	269	66
COMPLETED	65	222	64
NOT COMPLETED	5	47	2

Baseline Characteristics

Arm/Group Title	Conventional Patient Group	"Analimentary Detoxication"	Healthy People	Total
Arm/Group Description	Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day	Dietary Supplement - Vegetable and salt diet. Weight loss program "Analimentary detoxication" "Analimentary detoxication": Vegetable and salt diet	64 healthy people	Total of all reporting groups
Overall Participants	65	222	64	351
Age, Customized (years) [Mean (Standard Deviation) ]
Age	46.5 (13.6)	47.4 (12.8)	47.7 (12.3)	47.3 (12.9)
Sex: Female, Male (Count of Participants)
Female	34 52.3%	116 52.3%	34 53.1%	184 52.4%
Male	31 47.7%	106 47.7%	30 46.9%	167 47.6%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional Patient Group	"Analimentary Detoxication" Weight Loss	Healthy People
Arm/Group Description	Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day	Dietary Supplement - Vegetable and salt diet. Weight loss program "Analimentary detoxication" "Analimentary detoxication": Vegetable and salt diet	64 healthy people
Measure Participants	65	222	64
Fasting blood glucose level	6.05 (0.46)	6.43 (0.36)	4.58 (0.18)
Two-hour postprandial glucose	14.5 (0.28)	14.6 (0.28)	5.3 (0.14)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional Patient Group	"Analimentary Detoxication" Weight Loss	Healthy People
Arm/Group Description	Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day	Dietary Supplement - Vegetable and salt diet. Weight loss program "Analimentary detoxication" "Analimentary detoxication": Vegetable and salt diet	64 healthy people
Measure Participants	65	222	64
Systolic Blood Pressures	151.2 (1.1)	152.1 (1.1)	121.1 (0.7)
Diastolic Blood Pressures	94.1 (0.7)	96.9 (0.8)	79.9 (0.5)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional Patient Group	"Analimentary Detoxication" Weight Loss	Healthy People
Arm/Group Description	Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day	Dietary Supplement - Vegetable and salt diet. Weight loss program "Analimentary detoxication" "Analimentary detoxication": Vegetable and salt diet	64 healthy people
Measure Participants	65	222	64
Cholesterol	5.22 (0.18)	5.35 (0.17)	4.9 (0.14)
High-density Lipoproteids	0.76 (0.007)	0.75 (0.004)	1.22 (0.007)
Triglycerides	2.1 (0.18)	2.2 (0.12)	1.4 (0.09)

4. Secondary Outcome

Title	Immunoassay Hormones in Blood
Description	Immunoassay Insulin in the blood (in nU/L) was investigated
Time Frame	up to 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional Patient Group	"Analimentary Detoxication"	Healthy People
Arm/Group Description	Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day	Dietary Supplement - Vegetable and salt diet. Weight loss program "Analimentary detoxication" "Analimentary detoxication": Vegetable and salt diet	64 healthy people
Measure Participants	65	222	64
Mean (Standard Error) [nU/L]	22.9 (1.1)	23.2 (1.0)	6.5 (0.3)

5. Secondary Outcome

Title	Immunoassay Cortisole in Blood
Description	Immunoassay Cortisole in the blood (nmole/L) was measured
Time Frame	up to 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional Patient Group	"Analimentary Detoxication"	Healthy People
Arm/Group Description	Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day	Dietary Supplement - Vegetable and salt diet. Weight loss program "Analimentary detoxication" "Analimentary detoxication": Vegetable and salt diet	64 healthy people
Measure Participants	65	222	64
Mean (Standard Error) [nmol/L]	743.8 (6.9)	751.2 (6.7)	445.3 (5.3)

Adverse Events

Arm/Group Title	Conventional Patient Group		"Analimentary Detoxication"		Healthy People
Arm/Group Description	Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day		Dietary Supplement - Vegetable and salt diet. Weight loss program "Analimentary detoxication" "Analimentary detoxication": Vegetable and salt diet		64 healthy people
All Cause Mortality
	Conventional Patient Group		"Analimentary Detoxication"		Healthy People
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Conventional Patient Group		"Analimentary Detoxication"		Healthy People
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	29/65 (44.6%)		26/222 (11.7%)		0/64 (0%)
Gastrointestinal disorders
Indigestions	29/65 (44.6%)	78	26/222 (11.7%)	26	0/64 (0%)	0
Other (Not Including Serious) Adverse Events
	Conventional Patient Group		"Analimentary Detoxication"		Healthy People
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	49/65 (75.4%)		62/222 (27.9%)		0/64 (0%)
Cardiac disorders
hypertension	42/65 (64.6%)	164	26/222 (11.7%)	52	0/64 (0%)	0
General disorders
hypertermia	40/65 (61.5%)	160	62/222 (27.9%)	124	0/64 (0%)	0

Limitations/Caveats

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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.