NCT06410352RecruitingPhase 4
Effectiveness of Weight Loss Methods on Lifespan for Metabolic Syndrome
Effectiveness of Pharmacologic, Surgical, and Dietetic Weight Loss Methods on Lifespan in Patients With Metabolic Syndrome: a Comparative Clinical Trial
Source: ClinicalTrials.gov · Last updated 26 Nov 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 220 (estimated)
- First submitted
- 29 Apr 2024
- Start date
- 1 Mar 2024
- Primary completion date
- 30 Sept 2025
- Lead sponsor
- University Medical Center, Kazakhstan
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT06410352
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 220
- From 1 Mar 2024 to the primary completion date, 30 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- glomerular filtration rate \<30 mL/min and/or dialysis within 14 days before screening; • malignancy within the past 5 years;
Other illness
- unstable cardiac disorders (New York Heart Association class IV heart failure, refractory angina, uncontrolled arrhythmias, critical valvular heart disease, or severe uncontrolled hypertension);
- hereditary diseases;
- known hypersensitivity to any of the test substances.
Age
- \<34 age \>56 years old;
Other
- T1D;
- gestation or lactation;
Who the study is looking for
- 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.
Age in the registry: 35 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kuat Pernekulovich Oshakbayev Coordinator of this site? Confirm its status | Astana | Kazakhstan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.