Effectiveness of Weight Loss Methods on Lifespan for Metabolic Syndrome

NCT06410352 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: AP23488544
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

Background. The prevalence of type 2 diabetes mellitus (T2D) in the world is constantly increasing. Treatment of T2D is complicated by arterial hypertension and obesity (metabolic syndrome - MS). Cardiovascular complications are the main cause of death in patients with MS. Objective weight loss improves clinical and laboratory parameters in patients with T2D and hypertension. Purpose: To study lifespan, glycemic and lipid metabolism, quality of life, and cost-effectiveness of pharmacologic, surgical, and dietetic weight loss methods in obese patients with MS at 24 weeks in a comparative clinical trial. Methods:

1. 1.st stage - Study design: An open pilot prospective clinical trial. The study included 71 adult patients with T2D and hypertension for the Ramadan fast's (RF) weight loss.
2. 2.nd stage - Study design: A 24-week open label, prospective, multicenter, comparative clinical trial with the intention-to-treat analysis.
3. 3.at least three articles and/or reviews in peer-reviewed scientific publications indexed in the Science Citation Index Expanded of the Web Of Science database and/or having a Cite Score percentile in the Scopus of at least 50;
4. 4.at least 1 patent for an invention (including a positive decision on it).

Conditions

Metabolic Syndrome

Keywords

metabolic syndrome; obesity; type 2 diabetes mellitus; weight loss; telomere length; quality of life; cost effectiveness analysis

Outcome Measures

Primary Outcomes (7)

• Weight

  weight in kilograms

  Baseline, 24 weeks

• Body mass index

  weight and height will be combined to report BMI in kg/m\^2

  Baseline, 24 weeks

• Fat mass

  fat mass in % of total body weight and total kg

  Baseline, 24 weeks

• Fat free mass

  fat free mass in % of total body weight and total kg

  Baseline, 24 weeks

• blood insulin level

  Fasting serum insulin (nU/L) was determined by immunoassay (Immunotech Insulin Irma kit, Prague, Czech Republic)

  Baseline, 24 weeks

• systolic/diastolic Blood presure

  Blood pressure is measured in units of millimeters of mercury (mmHg). The readings are always given in pairs, with the upper (systolic) value first, followed by the lower (diastolic) value.

  Baseline, 24 weeks

• Fasting blood glucose

  mmol per liter

  Baseline, 24 weeks

Secondary Outcomes (4)

• Total cholesterol

  Baseline, 24 weeks

• HbA1c

  Baseline, 24 weeks

• Triglycerides

  Baseline, 24 weeks

• High-density lipoprotein

  Baseline, 24 weeks

Study Arms (4)

Pharmacologic weight loss (Combination Product)

ACTIVE COMPARATOR

The 1st group (n=50) receives subcutaneous Semaglutide (GLP-1RA) 1 mg once a 7 day with oral Empagliflozin (SGLT-2i) 25 mg once a day that is a novel combination additionally to standard medical treatment including anti-diabetes, antihypertensive, lipid-lowering, symptomatic therapy.

Drug: Semaglutide, Empagliflozin

Surgical weight loss

ACTIVE COMPARATOR

The 2nd group (n=50) receives surgical method (laparoscopic MGB). These patients pass through additional pre-operation examination (blood tests and electrocardiography, esophagogastroscopy, ultrasound, and other necessary standard methods).

Procedure: Minigastric bypass

Very-low-calorie-restriction diet

EXPERIMENTAL

The 3rd group (n=50) receives very-low-calorie-restriction diet ('Analimentary-detoxication') including \<100 kcal/day with fat-free vegetables (tomato/cucumber) and salt intake (5-6 g/day), optimum physical activity, and sexual self-restraint. The program goals the next outputs: a) use of own fatty store; b) control endogen intoxication; c) reuse of interim metabolic substrates.

Dietary Supplement: Analimentary detoxication

Ramadan fast's weight loss

EXPERIMENTAL

The 4th group (n=30) adheres to fasting on Ramadan fast (RF) season. They strictly adhered to two principles of nutrition during RF: 1) "no blood, no smell of fat" which means "don't eat meat and don't eat fatty foods"; 2) the 'Sehri time' (a meal eaten before dawn) included just 1.5-2.0 glass of water and fruits of 80-100 gr (apple, dates, and persimmon). Indeed, the patients followed a diet in which they ate one meal a day - participants have a meal during 'Iftar time' (a meal eaten after sunset).

Behavioral: Ramadan fast's weight loss

Interventions

Semaglutide, Empagliflozin DRUG

subcutaneous Semaglutide (GLP-1RA) 1 mg once a 7 day with oral Empagliflozin (SGLT-2i) 25 mg once a day

Also known as: Semaglutide (GLP-1RA), Empagliflozin (SGLT-2i)

Pharmacologic weight loss (Combination Product)

Minigastric bypass PROCEDURE

Endovideososcopic techniques with the intraperitoneal using of synthetic/biological materials. MGB is performed to reduce the absorption surface of the gastrointestinal tract by shunting the greater part of the stomach, the duodenum and the initial section of the small intestine, which reduces the absorption of food and leads to a decrease in the production of gastrointestinal hormones.

Also known as: bariatric operation

Surgical weight loss

Analimentary detoxication DIETARY_SUPPLEMENT

very-low-calorie-restriction diet ('Analimentary-detoxication') including \<100 kcal/day with fat-free vegetables (tomato/cucumber) and salt intake (5-6 g/day), optimum physical activity, and sexual self-restraint.

Also known as: Very-low-calorie diet

Very-low-calorie-restriction diet

Ramadan fast's weight loss BEHAVIORAL

The participants adhered to fasting on RF season. They strictly adhered to two principles of nutrition during RF: 1) "no blood, no smell of fat" which means "don't eat meat and don't eat fatty foods"; 2) the 'Sehri time' (a meal eaten before dawn) included just 1.5-2.0 glass of water and fruits of 80-100 gr (apple, dates, and persimmon). Indeed, the patients followed a diet in which they ate one meal a day - participants have a meal during 'Iftar time' (a meal eaten after sunset).

Also known as: Ramadan fast

Ramadan fast's weight loss

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• written informed consent;
• T2D≥3-year with glucose lowering therapy including insulin;
• years old;
• BMI≥27 kg/m2 for both sex, for Asian ethnicity;
• ongoing treatment with antihypertensive treatment;
• weight loss 15-20% at baseline and dynamic follow-up up to 24 weeks.

You may not qualify if:

• T1D;
• \<34 age \>56 years old;
• unstable cardiac disorders (New York Heart Association class IV heart failure, refractory angina, uncontrolled arrhythmias, critical valvular heart disease, or severe uncontrolled hypertension);
• glomerular filtration rate \<30 mL/min and/or dialysis within 14 days before screening; • malignancy within the past 5 years;
• gestation or lactation;
• hereditary diseases;
• known hypersensitivity to any of the test substances.

Sponsors & Collaborators

• University Medical Center, Kazakhstan: lead
• Nazarbayev University School of Medicine: collaborator
• Nazarbayev University: collaborator
• Astana Medical University: collaborator
• Public Association "Eurasian Society of Personalized Medicine": collaborator
• Ministry of Science and Higher Education of the Republic of Kazakhstan: collaborator

Study Sites (1)

Kuat Pernekulovich Oshakbayev

Astana, Astana, 010000, Kazakhstan

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome; Obesity; Diabetes Mellitus, Type 2; Weight Loss

Interventions

semaglutide; empagliflozin

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Endocrine System Diseases; Body Weight Changes

Study Officials

• Kuat Oshakbayev, professor

  University Medical Center, Kazakhstan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

full-professor Kuat Oshakbayev

CONTACT

+77013999394; okp.kuat@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: full-Professor

Model Details: One of the methods that will be used in project is a new drug combination for weight loss in patients with T2D - Glucagon-like-peptide-1-receptor-agonists with sodium-glucose-co-transporter-2-inhibitors. Guidelines on hyperglycemic management recommend either GLP-1RAs or SGLT-2is as second-line treatments for patients with T2D on metformin monotherapy. The use of both antidiabetic drugs in combination is rare in the literature. During the last decade, the results of large-scale, randomized, clinical trials on newer antidiabetic agents, GLP-1RA and SGLT-2 inhibitor have been shown to modify cardiovascular risk factors, such as insulin resistance, body weight, BP, and lipid profile, additionally to induce weight loss. The second method is a bariatric operation - minigastric bypass (MGB) that is endovideososcopic techniques with the intraperitoneal using of synthetic/biological materials. MGB is performed to reduce the absorption surface of the gastrointestinal

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 13, 2024
• Study Start: March 1, 2024
• Primary Completion: September 30, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)