NCT06410352

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
University Medical Center, Kazakhstan·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Metabolic Syndrome
Drug/Device/Intervention
Semaglutide, Empagliflozin
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
University Medical Center, Kazakhstan
Location
Astana, Kazakhstan
Timeline & enrollment
Phase
N/A
Start date
Mar 01, 2023
End date
Dec 31, 2026
Enrollment
220 participants
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
Metabolic disordersMetabolic disorder, unspecifiedOther metabolic disordersOther specified metabolic disordersNutritional and metabolic disorders in diseases classified elsewhere
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06410352
Type
Non-Device Trial
About this record

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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