Effectiveness of Weight Loss Methods on Lifespan for Metabolic Syndrome

Recruiting · NCT06410352 · Interventional (participants receive a specific treatment) · Lead sponsor: University Medical Center, Kazakhstan

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Obesity Type 2 diabetes

Interventions studied

Analimentary detoxicationMinigastric bypassRamadan fast's weight lossSemaglutide, Empagliflozin

What this trial 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).

Who can take part

Age range

35 Years to 65 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 4

Study type

Interventional (participants receive a specific treatment)

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.

Where it is running

1 location listed.

Kuat Pernekulovich Oshakbayev - Astana, Astana, Kazakhstan

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →