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Recruiting Phase 4

Effectiveness of Weight Loss Methods on Lifespan for Metabolic Syndrome

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About this study

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).

Condition
Metabolic Syndrome
Tested
Semaglutide, Empagliflozin, Minigastric bypass, Analimentary detoxication, Ramadan fast's weight loss
Sponsor
University Medical Center, Kazakhstan

Who can join

Age
35 to 65 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 9

  • Minimum age: 35 years
  • Maximum age: 65 years
  • Study condition: Metabolic Syndrome
  • 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 6

  • \<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

1 site, 1 recruiting

Kuat Pernekulovich Oshakbayev

Astana, Astana, Kazakhstan

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.