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| Name | Class |
|---|---|
| Institute Of Cardiology & Internal Diseases, Kazakhstan | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Lipid Profile | Blood sample for lipid profile (Cholesterol in mmole/L, High-density Lipoproteids in mmole/L, Triglycerides in mmole/L) was measured | up to 12 weeks |
| Immunoassay Hormones in Blood |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tabynbayev Nariman, Professor | Nazarbayev University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Republican Scientific Center for Emergency Medicine | Astana | Astana | 010000 | Kazakhstan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23451166 | Background | 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. | |
| 23176668 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | "Analimentary Detoxication" | Dietary Supplement - Vegetable and salt diet. Weight loss program "Analimentary detoxication" "Analimentary detoxication": Vegetable and salt diet |
| FG002 | Healthy People | 64 healthy people |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Blood Glucose Level | Fasting blood glucose (FBG) (mmole/L) and Two-hour postprandial glucose (THPG) (mmole/L) were measured. | Posted | Mean | Standard Error | mmole/L | up to 12 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Indigestions | Gastrointestinal disorders | Systematic Assessment | diarrhea, itching, gastritis |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hypertermia | General disorders | Systematic Assessment |
We acknowledge the randomized clinical trial have not a large sample size
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kuat Oshakbayev | Republican Scientific Center for Emergency care at Nazarbayev University | +77013999141 | okp.kuat@mail.ru |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D003920 | Diabetes Mellitus |
| D006973 | Hypertension |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077403 | Orlistat |
| D004110 | Diltiazem |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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|
| "Analimentary detoxication" | Dietary Supplement | Vegetable and salt diet |
|
|
Immunoassay Insulin in the blood (in nU/L) was investigated
| up to 12 weeks |
| Immunoassay Cortisole in Blood | Immunoassay Cortisole in the blood (nmole/L) was measured | up to 12 weeks |
| 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. |
| 22140269 | Result | 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. |
| 28163748 | Derived | 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. |
| "Analimentary Detoxication" |
Dietary Supplement - Vegetable and salt diet. Weight loss program "Analimentary detoxication" "Analimentary detoxication": Vegetable and salt diet |
| BG002 | Healthy People | 64 healthy people |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | Healthy People | 64 healthy people |
|
|
| Primary | Systolic/ Diastolic Blood Pressures (mm Hg) | Systolic and Diastolic Blood Pressures (mm Hg) was measured by manual/automatic tonometery | Posted | Mean | Standard Error | mm Hg | up to 12 weeks |
|
|
|
| Secondary | Lipid Profile | Blood sample for lipid profile (Cholesterol in mmole/L, High-density Lipoproteids in mmole/L, Triglycerides in mmole/L) was measured | Posted | Mean | Standard Error | mmole/L | up to 12 weeks |
|
|
|
| Secondary | Immunoassay Hormones in Blood | Immunoassay Insulin in the blood (in nU/L) was investigated | Posted | Mean | Standard Error | nU/L | up to 12 weeks |
|
|
|
| Secondary | Immunoassay Cortisole in Blood | Immunoassay Cortisole in the blood (nmole/L) was measured | Posted | Mean | Standard Error | nmol/L | up to 12 weeks |
|
|
|
| 29 |
| 65 |
| 49 |
| 65 |
| EG001 | "Analimentary Detoxication" | Dietary Supplement - Vegetable and salt diet. Weight loss program "Analimentary detoxication" "Analimentary detoxication": Vegetable and salt diet | 26 | 222 | 62 | 222 |
| EG002 | Healthy People | 64 healthy people | 0 | 64 | 0 | 64 |
|
| hypertension | Cardiac disorders | Systematic Assessment |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
|
|
| Triglycerides |
|