Effectiveness of Weight Loss Methods on Lifespan for Metabolic Syndrome - Trial NCT06410352
Access comprehensive clinical trial information for NCT06410352 through Pure Global AI's free database. This phase not specified trial is sponsored by University Medical Center, Kazakhstan and is currently Recruiting. The study focuses on Metabolic Syndrome. Target enrollment is 220 participants.
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Study Focus
Sponsor & Location
University Medical Center, Kazakhstan
Timeline & Enrollment
N/A
Mar 01, 2023
Dec 31, 2026
Primary Outcome
Weight,Body mass index,Fat mass,Fat free mass,blood insulin level,systolic/diastolic Blood presure,Fasting blood glucose
Summary
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).
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06410352
Non-Device Trial