Trial Outcomes & Findings for Development of Rational Ways of Medical and Non-medical Treatment Methods for Metabolic Syndrome (NCT NCT02503865)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

351 participants

Primary outcome timeframe

up to 12 weeks

Results posted on

2015-11-30

Participant Flow

Participant milestones

Participant milestones
Measure	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	"Analimentary Detoxication" Dietary Supplement - Vegetable and salt diet. Weight loss program "Analimentary detoxication" "Analimentary detoxication": Vegetable and salt diet	Healthy People 64 healthy people
Overall Study STARTED	70	269	66
Overall Study COMPLETED	65	222	64
Overall Study NOT COMPLETED	5	47	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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	"Analimentary Detoxication" Dietary Supplement - Vegetable and salt diet. Weight loss program "Analimentary detoxication" "Analimentary detoxication": Vegetable and salt diet	Healthy People 64 healthy people
Overall Study Moved out of area	1	8	0
Overall Study Refused treatment	4	39	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Conventional Patient Group n=65 Participants 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	"Analimentary Detoxication" n=222 Participants Dietary Supplement - Vegetable and salt diet. Weight loss program "Analimentary detoxication" "Analimentary detoxication": Vegetable and salt diet	Healthy People n=64 Participants 64 healthy people	Total n=351 Participants Total of all reporting groups
Age, Customized Age	46.5 years STANDARD_DEVIATION 13.6 • n=5 Participants	47.4 years STANDARD_DEVIATION 12.8 • n=7 Participants	47.7 years STANDARD_DEVIATION 12.3 • n=5 Participants	47.3 years STANDARD_DEVIATION 12.9 • n=4 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	116 Participants n=7 Participants	34 Participants n=5 Participants	184 Participants n=4 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	106 Participants n=7 Participants	30 Participants n=5 Participants	167 Participants n=4 Participants

PRIMARY outcome

Timeframe: up to 12 weeks

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

Outcome measures

Outcome measures
Measure	Conventional Patient Group n=65 Participants 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	"Analimentary Detoxication" Weight Loss n=222 Participants Dietary Supplement - Vegetable and salt diet. Weight loss program "Analimentary detoxication" "Analimentary detoxication": Vegetable and salt diet	Healthy People n=64 Participants 64 healthy people
Blood Glucose Level Fasting blood glucose level	6.05 mmole/L Standard Error 0.46	6.43 mmole/L Standard Error 0.36	4.58 mmole/L Standard Error 0.18
Blood Glucose Level Two-hour postprandial glucose	14.5 mmole/L Standard Error 0.28	14.6 mmole/L Standard Error 0.28	5.3 mmole/L Standard Error 0.14

PRIMARY outcome

Timeframe: up to 12 weeks

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

Outcome measures

Outcome measures
Measure	Conventional Patient Group n=65 Participants 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	"Analimentary Detoxication" Weight Loss n=222 Participants Dietary Supplement - Vegetable and salt diet. Weight loss program "Analimentary detoxication" "Analimentary detoxication": Vegetable and salt diet	Healthy People n=64 Participants 64 healthy people
Systolic/ Diastolic Blood Pressures (mm Hg) Diastolic Blood Pressures	94.1 mm Hg Standard Error 0.7	96.9 mm Hg Standard Error 0.8	79.9 mm Hg Standard Error 0.5
Systolic/ Diastolic Blood Pressures (mm Hg) Systolic Blood Pressures	151.2 mm Hg Standard Error 1.1	152.1 mm Hg Standard Error 1.1	121.1 mm Hg Standard Error 0.7

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Conventional Patient Group n=65 Participants 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	"Analimentary Detoxication" Weight Loss n=222 Participants Dietary Supplement - Vegetable and salt diet. Weight loss program "Analimentary detoxication" "Analimentary detoxication": Vegetable and salt diet	Healthy People n=64 Participants 64 healthy people
Lipid Profile Cholesterol	5.22 mmole/L Standard Error 0.18	5.35 mmole/L Standard Error 0.17	4.9 mmole/L Standard Error 0.14
Lipid Profile High-density Lipoproteids	0.76 mmole/L Standard Error 0.007	0.75 mmole/L Standard Error 0.004	1.22 mmole/L Standard Error 0.007
Lipid Profile Triglycerides	2.1 mmole/L Standard Error 0.18	2.2 mmole/L Standard Error 0.12	1.4 mmole/L Standard Error 0.09

SECONDARY outcome

Timeframe: up to 12 weeks

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

Outcome measures

Outcome measures
Measure	Conventional Patient Group n=65 Participants 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	"Analimentary Detoxication" Weight Loss n=222 Participants Dietary Supplement - Vegetable and salt diet. Weight loss program "Analimentary detoxication" "Analimentary detoxication": Vegetable and salt diet	Healthy People n=64 Participants 64 healthy people
Immunoassay Hormones in Blood	22.9 nU/L Standard Error 1.1	23.2 nU/L Standard Error 1.0	6.5 nU/L Standard Error 0.3

SECONDARY outcome

Timeframe: up to 12 weeks

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

Outcome measures

Outcome measures
Measure	Conventional Patient Group n=65 Participants 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	"Analimentary Detoxication" Weight Loss n=222 Participants Dietary Supplement - Vegetable and salt diet. Weight loss program "Analimentary detoxication" "Analimentary detoxication": Vegetable and salt diet	Healthy People n=64 Participants 64 healthy people
Immunoassay Cortisole in Blood	743.8 nmol/L Standard Error 6.9	751.2 nmol/L Standard Error 6.7	445.3 nmol/L Standard Error 5.3

Adverse Events

Conventional Patient Group

Serious events: 29 serious events

Other events: 49 other events

Deaths: 0 deaths

"Analimentary Detoxication"

Serious events: 26 serious events

Other events: 62 other events

Deaths: 0 deaths

Healthy People

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Conventional Patient Group n=65 participants at risk 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	"Analimentary Detoxication" n=222 participants at risk Dietary Supplement - Vegetable and salt diet. Weight loss program "Analimentary detoxication" "Analimentary detoxication": Vegetable and salt diet	Healthy People n=64 participants at risk 64 healthy people
Gastrointestinal disorders Indigestions	44.6% 29/65 • Number of events 78	11.7% 26/222 • Number of events 26	0.00% 0/64

Other adverse events

Other adverse events
Measure	Conventional Patient Group n=65 participants at risk 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	"Analimentary Detoxication" n=222 participants at risk Dietary Supplement - Vegetable and salt diet. Weight loss program "Analimentary detoxication" "Analimentary detoxication": Vegetable and salt diet	Healthy People n=64 participants at risk 64 healthy people
General disorders hypertermia	61.5% 40/65 • Number of events 160	27.9% 62/222 • Number of events 124	0.00% 0/64
Cardiac disorders hypertension	64.6% 42/65 • Number of events 164	11.7% 26/222 • Number of events 52	0.00% 0/64

Additional Information

Dr. Kuat Oshakbayev

Republican Scientific Center for Emergency care at Nazarbayev University

Phone: +77013999141

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place