Health TrialsbyHealthPanel

Effectiveness of Weight Loss Methods on Lifespan for Metabolic Syndrome

ConditionMetabolic Syndrome
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age35-65
SponsorUniversity Medical Center, Kazakhstan

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Semaglutide, Empagliflozin

    Drug

    subcutaneous Semaglutide (GLP-1RA) 1 mg once a 7 day with oral Empagliflozin (SGLT-2i) 25 mg once a day

  • Minigastric bypass

    Procedure/Surgery

    Endovideososcopic techniques with the intraperitoneal using of synthetic/biological materials. MGB is performed to reduce the absorption surface of the gastrointestinal tract by shunting the greater part of the stomach, the duodenum and the initial section of the small intestine, which reduces the absorption of food and leads to a decrease in the production of gastrointestinal hormones.

  • Analimentary detoxication

    Dietary supplement

    very-low-calorie-restriction diet ('Analimentary-detoxication') including \<100 kcal/day with fat-free vegetables (tomato/cucumber) and salt intake (5-6 g/day), optimum physical activity, and sexual self-restraint.

  • Ramadan fast's weight loss

    Behavioral

    The participants adhered to fasting on RF season. They strictly adhered to two principles of nutrition during RF: 1) "no blood, no smell of fat" which means "don't eat meat and don't eat fatty foods"; 2) the 'Sehri time' (a meal eaten before dawn) included just 1.5-2.0 glass of water and fruits of 80-100 gr (apple, dates, and persimmon). Indeed, the patients followed a diet in which they ate one meal a day - participants have a meal during 'Iftar time' (a meal eaten after sunset).

Treatment groups

220 Participants
are divided into 4 treatment groups
Group A: Pharmacologic weight loss (Combination Product)Active comparator 1 intervention
Group B: Surgical weight lossActive comparator 1 intervention
Group C: Very-low-calorie-restriction dietExperimental treatment 1 intervention
Group D: Ramadan fast's weight lossExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Weight

weight in kilograms

Time frame
Baseline, 24 weeks
2

Body mass index

weight and height will be combined to report BMI in kg/m\^2

Time frame
Baseline, 24 weeks
3

Fat mass

fat mass in % of total body weight and total kg

Time frame
Baseline, 24 weeks
4

Fat free mass

fat free mass in % of total body weight and total kg

Time frame
Baseline, 24 weeks

Secondary outcomes

1

Total cholesterol

Total cholesterol in mmol/l

Time frame
Baseline, 24 weeks
2

HbA1c

glycosilated hemoglobin in % or/and mmol/mol

Time frame
Baseline, 24 weeks
3

Triglycerides

Triglycerides in gr/L

Time frame
Baseline, 24 weeks
4

High-density lipoprotein

high-density lipoprotein i n mmol/L

Time frame
Baseline, 24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Medical Center, Kazakhstan

Lead sponsor

Nazarbayev University School of Medicine

Collaborator

Nazarbayev University

Collaborator

Astana Medical University

Collaborator

Public Association "Eurasian Society of Personalized Medicine"

Collaborator

Ministry of Science and Higher Education of the Republic of Kazakhstan

Collaborator

Source ClinicalTrials.gov
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