Title

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

    Phase 1/Phase 2
  • Study Type

    Interventional
  • Study Participants

    351
Metabolic syndrome: aetiology, pathogenesis, diagnosis, clinical management and prognosis
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 Started
Jan 31
2003
Primary Completion
Dec 31
2008
Study Completion
Dec 31
2014
Results Posted
Nov 03
2015
Estimate
Last Update
Nov 30
2015
Estimate

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

Dietary Supplement "Analimentary detoxication"

Vegetable and salt diet

  • Other names: Experimental Patient group

Conventional Patient group Active Comparator

Xenical, Pionorm, Diroton, Diltiazem, Atorvastatin

"Analimentary detoxication" Weight loss Experimental

Vegetables and salt diet

Healthy people No Intervention

64 healthy people

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

Summary

Conventional Patient Group

"Analimentary Detoxication"

Healthy People

All Events

Event Type Organ System Event Term Conventional Patient Group "Analimentary Detoxication" Healthy People

Blood Glucose Level

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

Conventional Patient Group

Fasting blood glucose level

6.05
mmole/L (Mean)
Standard Error: 0.46

Two-hour postprandial glucose

14.5
mmole/L (Mean)
Standard Error: 0.28

"Analimentary Detoxication" Weight Loss

Fasting blood glucose level

6.43
mmole/L (Mean)
Standard Error: 0.36

Two-hour postprandial glucose

14.6
mmole/L (Mean)
Standard Error: 0.28

Healthy People

Fasting blood glucose level

4.58
mmole/L (Mean)
Standard Error: 0.18

Two-hour postprandial glucose

5.3
mmole/L (Mean)
Standard Error: 0.14

Systolic/ Diastolic Blood Pressures (mm Hg)

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

Conventional Patient Group

Diastolic Blood Pressures

94.1
mm Hg (Mean)
Standard Error: 0.7

Systolic Blood Pressures

151.2
mm Hg (Mean)
Standard Error: 1.1

"Analimentary Detoxication" Weight Loss

Diastolic Blood Pressures

96.9
mm Hg (Mean)
Standard Error: 0.8

Systolic Blood Pressures

152.1
mm Hg (Mean)
Standard Error: 1.1

Healthy People

Diastolic Blood Pressures

79.9
mm Hg (Mean)
Standard Error: 0.5

Systolic Blood Pressures

121.1
mm Hg (Mean)
Standard Error: 0.7

Lipid Profile

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

Conventional Patient Group

Cholesterol

5.22
mmole/L (Mean)
Standard Error: 0.18

High-density Lipoproteids

0.76
mmole/L (Mean)
Standard Error: 0.007

Triglycerides

2.1
mmole/L (Mean)
Standard Error: 0.18

"Analimentary Detoxication" Weight Loss

Cholesterol

5.35
mmole/L (Mean)
Standard Error: 0.17

High-density Lipoproteids

0.75
mmole/L (Mean)
Standard Error: 0.004

Triglycerides

2.2
mmole/L (Mean)
Standard Error: 0.12

Healthy People

Cholesterol

4.9
mmole/L (Mean)
Standard Error: 0.14

High-density Lipoproteids

1.22
mmole/L (Mean)
Standard Error: 0.007

Triglycerides

1.4
mmole/L (Mean)
Standard Error: 0.09

Immunoassay Hormones in Blood

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

Conventional Patient Group

22.9
nU/L (Mean)
Standard Error: 1.1

"Analimentary Detoxication"

23.2
nU/L (Mean)
Standard Error: 1.0

Healthy People

6.5
nU/L (Mean)
Standard Error: 0.3

Immunoassay Cortisole in Blood

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

Conventional Patient Group

743.8
nmol/L (Mean)
Standard Error: 6.9

"Analimentary Detoxication"

751.2
nmol/L (Mean)
Standard Error: 6.7

Healthy People

445.3
nmol/L (Mean)
Standard Error: 5.3

Total

351
Participants

Age, Customized

Sex: Female, Male

Overall Study

Conventional Patient Group

"Analimentary Detoxication"

Healthy People

Drop/Withdrawal Reasons

Conventional Patient Group

"Analimentary Detoxication"

Healthy People