Clinical trial

Effectiveness of Weight Loss Methods on Lifespan for Metabolic Syndrome

Recruiting now · Phase 4 · 1 countries · Registry ID NCT06410352

Recruiting nowPhase 4Interventional

What this study is about

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).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age35 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionMetabolic Syndrome

Full registry criteria

Inclusion Criteria: * written informed consent; * T2D≥3-year with glucose lowering therapy including insulin; * 35-55 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. Exclusion Criteria: * 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.

Treatments and study arms

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).

Primary outcomes

WeightBaseline, 24 weeks

weight in kilograms

Body mass indexBaseline, 24 weeks

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

Fat massBaseline, 24 weeks

fat mass in % of total body weight and total kg

Fat free massBaseline, 24 weeks

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

blood insulin levelBaseline, 24 weeks

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

systolic/diastolic Blood presureBaseline, 24 weeks

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.

Fasting blood glucoseBaseline, 24 weeks

mmol per liter

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Kuat Pernekulovich Oshakbayev🌐 Astana, Astana, Kazakhstan

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Kuat P Oshakbayev, professorContact

Email · Call +77013999394