Effectiveness of Weight Loss Methods on Lifespan for Metabolic Syndrome

Sponsor
University Medical Center, Kazakhstan
Study ID
NCT06410352
Phase
PHASE4
Status
Recruiting
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Conditions

  • Metabolic Syndrome

Eligibility Criteria

Sex
ALL
Age
35 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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. 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. nd stage - Study design: A 24-week open label, prospective, multicenter, comparative clinical trial with the intention-to-treat analysis. Participants. Totally 150 adult patients with MS aged 35-65 years and with BMI≥27 kg/m2 for Asian will be included. They will be distributed in three comparative groups: drug treatment, surgery and diet. Primary endpoints: weight loss, fasting blood glucose, blood insulin level, systolic/diastolic BP. Secondary endpoints: blood lipids, heel bone mineral density (HBMD), and ejection fraction (EF). Expected results: A prospective multicenter clinical study will provide comparative results on life expectancy, glycemic and lipid metabolism, quality of life, cost-effectiveness of pharmacological, bariatric and dietary methods of weight loss in patients with obesity, T2D and hypertension. As a result of the research, the following will be published: 1. 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; 2. at least 1 patent for an invention (including a positive decision on it).

Key Dates

Start date
Mar 1, 2024
Status verified
Nov 2025
Primary completion
Sep 30, 2025
Completion
Jul 31, 2026

Study Design

Enrollment
220 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Pharmacologic weight loss (Combination Product)
    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.
  • Active Comparator: Surgical weight loss
    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).
  • Experimental: Very-low-calorie-restriction diet
    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.
  • Experimental: Ramadan fast's weight loss
    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).

Primary Outcome Measure

Weight [ Time Frame: Baseline, 24 weeks ]

Central Contacts

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