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Effectiveness of Weight Loss Methods on Lifespan for Metabolic Syndrome

RecruitingPhase 4Ages 35 Years - 65 YearsAllUniversity Medical Center, Kazakhstan
NCT06410352 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 w

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📋 Eligibility rules (as published)
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.
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What it tests

  • Semaglutide, Empagliflozin
  • Minigastric bypass
  • Analimentary detoxication
  • Ramadan fast's weight loss
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Where

1 site
Kuat Pernekulovich Oshakbayev
Astana, Kazakhstan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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