Actively Recruiting
Effectiveness of Weight Loss Methods on Lifespan for Metabolic Syndrome
Led by University Medical Center, Kazakhstan · Updated on 2025-11-26
220
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
Sponsors
U
University Medical Center, Kazakhstan
Lead Sponsor
N
Nazarbayev University School of Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Effectiveness of Weight Loss Methods on Lifespan for Metabolic Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent
- Type 2 diabetes for at least 3 years with glucose-lowering therapy including insulin
- Age between 35 and 55 years
- Body mass index (BMI) of 27 kg/m2 or higher for Asian ethnicity
- Ongoing antihypertensive treatment
- Weight loss of 15-20% at baseline and during follow-up up to 24 weeks
You will not qualify if you...
- Type 1 diabetes
- Age below 34 or above 56 years
- Unstable cardiac disorders including New York Heart Association class IV heart failure, refractory angina, uncontrolled arrhythmias, critical valvular heart disease, or severe uncontrolled hypertension
- Glomerular filtration rate less than 30 mL/min or dialysis within 14 days before screening
- Malignancy within the past 5 years
- Pregnancy or lactation
- Hereditary diseases
- Known hypersensitivity to any of the test substances
AI-Screening
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Trial Site Locations
Total: 1 location
1
Kuat Pernekulovich Oshakbayev
Astana, Astana, Kazakhstan, 010000
Actively Recruiting
Research Team
F
full-professor Kuat Oshakbayev
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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