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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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02503865
Acronym
DRWMNTMS
Enrollment
351
Registered
2015-07-21
Start date
2003-01-31
Completion date
2014-12-31
Last updated
2015-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome

Keywords

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

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.

Interventions

DRUGXenical, 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_SUPPLEMENTAnalimentary detoxication

Vegetable and salt diet

Sponsors

Institute Of Cardiology & Internal Diseases, Kazakhstan
CollaboratorOTHER_GOV
Nazarbayev University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to 74 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Blood Glucose Levelup to 12 weeksFasting blood glucose (FBG) (mmole/L) and Two-hour postprandial glucose (THPG) (mmole/L) were measured.
Systolic/ Diastolic Blood Pressures (mm Hg)up to 12 weeksSystolic and Diastolic Blood Pressures (mm Hg) was measured by manual/automatic tonometery

Secondary

MeasureTime frameDescription
Lipid Profileup to 12 weeksBlood sample for lipid profile (Cholesterol in mmole/L, High-density Lipoproteids in mmole/L, Triglycerides in mmole/L) was measured
Immunoassay Hormones in Bloodup to 12 weeksImmunoassay Insulin in the blood (in nU/L) was investigated
Immunoassay Cortisole in Bloodup to 12 weeksImmunoassay Cortisole in the blood (nmole/L) was measured

Countries

Kazakhstan

Participant flow

Participants by arm

ArmCount
Conventional Patient Group
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
65
Analimentary Detoxication
Dietary Supplement - Vegetable and salt diet. Weight loss program Analimentary detoxication Analimentary detoxication: Vegetable and salt diet
222
Healthy People
64 healthy people
64
Total351

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyMoved out of area180
Overall StudyRefused treatment4392

Baseline characteristics

CharacteristicConventional Patient GroupAnalimentary DetoxicationHealthy PeopleTotal
Age, Customized
Age
46.5 years
STANDARD_DEVIATION 13.6
47.4 years
STANDARD_DEVIATION 12.8
47.7 years
STANDARD_DEVIATION 12.3
47.3 years
STANDARD_DEVIATION 12.9
Sex: Female, Male
Female
34 Participants116 Participants34 Participants184 Participants
Sex: Female, Male
Male
31 Participants106 Participants30 Participants167 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
49 / 6562 / 2220 / 64
serious
Total, serious adverse events
29 / 6526 / 2220 / 64

Outcome results

Primary

Blood Glucose Level

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

Time frame: up to 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Conventional Patient GroupBlood Glucose LevelFasting blood glucose level6.05 mmole/LStandard Error 0.46
Conventional Patient GroupBlood Glucose LevelTwo-hour postprandial glucose14.5 mmole/LStandard Error 0.28
Analimentary Detoxication Weight LossBlood Glucose LevelFasting blood glucose level6.43 mmole/LStandard Error 0.36
Analimentary Detoxication Weight LossBlood Glucose LevelTwo-hour postprandial glucose14.6 mmole/LStandard Error 0.28
Healthy PeopleBlood Glucose LevelFasting blood glucose level4.58 mmole/LStandard Error 0.18
Healthy PeopleBlood Glucose LevelTwo-hour postprandial glucose5.3 mmole/LStandard Error 0.14
Primary

Systolic/ Diastolic Blood Pressures (mm Hg)

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

Time frame: up to 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Conventional Patient GroupSystolic/ Diastolic Blood Pressures (mm Hg)Systolic Blood Pressures151.2 mm HgStandard Error 1.1
Conventional Patient GroupSystolic/ Diastolic Blood Pressures (mm Hg)Diastolic Blood Pressures94.1 mm HgStandard Error 0.7
Analimentary Detoxication Weight LossSystolic/ Diastolic Blood Pressures (mm Hg)Systolic Blood Pressures152.1 mm HgStandard Error 1.1
Analimentary Detoxication Weight LossSystolic/ Diastolic Blood Pressures (mm Hg)Diastolic Blood Pressures96.9 mm HgStandard Error 0.8
Healthy PeopleSystolic/ Diastolic Blood Pressures (mm Hg)Systolic Blood Pressures121.1 mm HgStandard Error 0.7
Healthy PeopleSystolic/ Diastolic Blood Pressures (mm Hg)Diastolic Blood Pressures79.9 mm HgStandard Error 0.5
Secondary

Immunoassay Cortisole in Blood

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

Time frame: up to 12 weeks

ArmMeasureValue (MEAN)Dispersion
Conventional Patient GroupImmunoassay Cortisole in Blood743.8 nmol/LStandard Error 6.9
Analimentary Detoxication Weight LossImmunoassay Cortisole in Blood751.2 nmol/LStandard Error 6.7
Healthy PeopleImmunoassay Cortisole in Blood445.3 nmol/LStandard Error 5.3
Secondary

Immunoassay Hormones in Blood

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

Time frame: up to 12 weeks

ArmMeasureValue (MEAN)Dispersion
Conventional Patient GroupImmunoassay Hormones in Blood22.9 nU/LStandard Error 1.1
Analimentary Detoxication Weight LossImmunoassay Hormones in Blood23.2 nU/LStandard Error 1
Healthy PeopleImmunoassay Hormones in Blood6.5 nU/LStandard Error 0.3
Secondary

Lipid Profile

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

ArmMeasureGroupValue (MEAN)Dispersion
Conventional Patient GroupLipid ProfileHigh-density Lipoproteids0.76 mmole/LStandard Error 0.007
Conventional Patient GroupLipid ProfileTriglycerides2.1 mmole/LStandard Error 0.18
Conventional Patient GroupLipid ProfileCholesterol5.22 mmole/LStandard Error 0.18
Analimentary Detoxication Weight LossLipid ProfileCholesterol5.35 mmole/LStandard Error 0.17
Analimentary Detoxication Weight LossLipid ProfileHigh-density Lipoproteids0.75 mmole/LStandard Error 0.004
Analimentary Detoxication Weight LossLipid ProfileTriglycerides2.2 mmole/LStandard Error 0.12
Healthy PeopleLipid ProfileCholesterol4.9 mmole/LStandard Error 0.14
Healthy PeopleLipid ProfileTriglycerides1.4 mmole/LStandard Error 0.09
Healthy PeopleLipid ProfileHigh-density Lipoproteids1.22 mmole/LStandard Error 0.007

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026