Effectiveness of Pharmacologic, Surgical, and Dietetic Weight Loss Methods on Lifespan in Patients with Metabolic Syndrome: a Comparative Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Dietary supplement, Procedure, Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 35
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Kazakhstan
Kuat Pernekulovich Oshakbayev
RECRUITING
Astana
Contact Information
Primary
full-professor Kuat Oshakbayev
okp.kuat@gmail.com
+77013999394
Time Frame
Start Date: 2023-03-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 220
Treatments
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).
Sponsors
Collaborators: Ministry of Science and Higher Education of the Republic of Kazakhstan, Nazarbayev University, Nazarbayev University School of Medicine, Astana Medical University
Leads: University Medical Center, Kazakhstan

This content was sourced from clinicaltrials.gov