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Study of the Life Expectancy of Patients With Metabolic Syndrome After Weight Loss: (LIFEXPE-RT)

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ClinicalTrials.gov Identifier: NCT03667469
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Oral Ospanov, University Medical Center, Kazakhstan

Brief Summary:

Background and study aims:

Surgical and non-surgical normalization of body weight with obesity leads to a significant improvement in health and regression of metabolic syndrome. But as the reduction in body weight with obesity changes the life expectancy remains not clear enough.

The use of endoscopic staplers does not exclude the emergence of serious complications of surgery, for example, including bleeding and leakage in the stapler suture line. Therefore, the advantages of using a band in the bariatrics are justified from a security standpoint.

Currently, the gastric bypass is increasingly performed in the version of the mini gastric bypass (MGB). Another name for the procedure: one anastomosis gastric bypass (OAGB). The proposal to use for the staple-free (stepleless or steplerless) creation of a pouch (band-separated gastric bypass) with use for band a vascular prosthesis is justified, but it requires comparison of this method with a stapler variant.

An important issue is comparing surgical and non-surgical weight loss with obesity and metabolic syndrome and comparing life expectancy with confirmation of changes in telomere length.

This study compares loss of weight, changes in other health conditions that the patient may have (co-morbidities, such as diabetes), telomere length, quality of life, the number of complications and side effects, the degree of complexity of the surgical technique and operating costs of a new laparoscopic band-separated mini- gastric bypass (LBSMGB) procedure compared with the standard stapler (linear cutter) - separated mini-gastric bypass (LSSMGB). Additionally, surgical treatment will be compared with non-surgical treatment (hypocaloric diet therapy).

Who can participate? Obese adult patients with a BMI of between 30 kg/m2 and 50 kg/m2. What does the study involve? Participants are randomly allocated to one of three groups. Those in the first (A) group undergo the laparoscopic band-separated mini-gastric bypass procedure. Those in the second (B) group undergo the linear cutter stapler-separated mini-gastric bypass procedure. In three (C) group including standard lifestyle intervention on weight and hypocaloric diet therapy.

All patients are then followed up one month after surgery and again after 6 and, finally, 12 months after surgery where the changing body mass index, changes in co-morbidities, change telomere length and quality of life are assessed.


Condition or disease Intervention/treatment Phase
Obesity Procedure: gastric bypass Dietary Supplement: Hypocaloric diet therapy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Participants are randomly allocated to one of three groups:

  1. Surgical bariatric procedure in the first (A) group undergo the laparoscopic band-separated mini-gastric bypass procedure: Gastric band (vascular prosthesis 8mm diameter and 7 cm length) was introduced in the abdomen and retracted through the retrogastric tunnel.
  2. Surgical bariatric procedure in the second (B) group: Linear cutter stapler-separated mini-gastric bypass (MGB/OAGB): standard surgery.
  3. Non-Surgical interventional in three (C) group including hypocaloric diet therapy.
Masking: Single (Outcomes Assessor)
Masking Description: sealed non-transparent envelopes
Primary Purpose: Treatment
Official Title: A Study of Life Expectancy in Patients With Metabolic Syndrome After Weight Loss: a Comparative Randomized Clinical Trial
Actual Study Start Date : May 24, 2018
Estimated Primary Completion Date : November 4, 2019
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LBSMGB
Laparoscopic band-separated mini-gastric bypass procedures
Procedure: gastric bypass
Laparoscopic surgical bariatric procedure with creation gastric pouch. A jejunal loop was created about 200 cm from the ligament of Treitz and anastomosed to the gastric pouch.
Other Name: MGB/OAGB

Active Comparator: LSSMGB
Laparoscopic stapler-separated mini-gastric bypass procedures
Procedure: gastric bypass
Laparoscopic surgical bariatric procedure with creation gastric pouch. A jejunal loop was created about 200 cm from the ligament of Treitz and anastomosed to the gastric pouch.
Other Name: MGB/OAGB

Active Comparator: Hypocaloric diet therapy
Hypocaloric diet therapy with energy restriction (-500 kcal/d)
Dietary Supplement: Hypocaloric diet therapy
Hypocaloric diet therapy with energy restriction (-500 kcal/d)




Primary Outcome Measures :
  1. Change of body mass index [ Time Frame: Baseline, at 6 months and then 12 months after surgery ]
    The measure is assessing a change of body mass index before and after the intervention. Weight (kg) and height (cm) will be combined with the report of measurement by body mass index (BMI) kg/m2.


Secondary Outcome Measures :
  1. Changes of comorbidities [ Time Frame: Baseline, at 6 months and then 12 months after surgery ]
    Changes in co-morbidities by evaluation of symptoms: diabetes improved or resolved in % of patients, hyperlipidemia improved in %, hypertension improved or resolved in %, and obstructive sleep apnea improved or resolved in % of patients

  2. Changes in the length of leukocyte telomere [ Time Frame: Baseline, at 6 months and then 12 months after surgery ]
    To determine changes in the length of leukocyte telomer (TL) in patients of three groups

  3. Change of Quality of life [ Time Frame: at 6 months and then 12 months after surgery ]

    Quality of life, measured by the quality of life questionnaire the Moorehead-Ardelt Quality of Life Questionnaire II. 6 key areas were examined: self-esteem, physical well-being, social relationships, work, sexuality and eating behavior.The sum of these 6 scores generates an overall QoL score. Each score is classified into 5 categories (very poor: -3.0 to -2.1; poor: -2.0 to -1.1; fair: -1.0 to +1.0; good: 1.1 to 2.0: and very good: 2.1 to 3.0).the Quality of life of patients after weight loss is estimated as follows:

    • Poor ≤1
    • Satisfactory> 1 to 3
    • Good> 3 to 5
    • Very good > 5 to 7
    • Excellent> 7 to 9



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI from 30 to 50 kg / m2;
  • Metabolic syndrome (MetS) with abdominal adiposity if there are at least two components of MetS from the following: Increase in fasting plasma glucose: detected before diabetes (HbA1 = 5.7-6.4 or 3-fold increase in fasting plasma glucose:> 5.6 mmol / l); or previously diagnosed type 2 diabetes (HbA1> 6.5, or glucose> 6.1); Arterial hypertension AD 130 / 85 mmHg or receiving antihypertensive therapy; Increased triglyceride levels> 1.7 mmol / L or a specific treatment for this disorder; Reduction of high-density lipoproteins (HDL-C) <1.03 mmol / L in men and less than 1.29 mmol / L in women or receiving treatment for this disorder;
  • The possibility of treatment for 6 months and the possibility of follow up;
  • Informed written consent of the patient for randomization and treatment.

Exclusion Criteria:

  • Age is less than 18 or more than 65 years;
  • BMI less than 30 kg / m2 and more than 50 kg / m2;
  • Drug addiction and alcohol consumption;
  • Complete immobilization of the patient (paresis / paralysis);
  • Presence in the anamnesis bariatric procedures;
  • Insulin-dependent diabetes;
  • Mental disorders or taking antidepressants;
  • Socially vulnerable categories (according to ethical principles);
  • Patients who do not understand the purpose of the study;
  • Lack of informed written consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03667469


Contacts
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Contact: Oral B Ospanov, Prof. +77015287734 bariatric.kz@gmail.com
Contact: Alma A Syzdykova, PhD +77014202882 alma.syzdykova@umc.org.kz

Locations
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Kazakhstan
National Scientific Center for Oncology and Transplantation Recruiting
Astana, Kazakhstan, 010000
Contact: Oral B Ospanov, Prof.    +77015287734    bariatric.kz@gmail.com   
Contact: Alma A Syzdykova, PhD    +77014202882    alma.syzdykova@umc.org.kz   
Sponsors and Collaborators
University Medical Center, Kazakhstan
Investigators
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Principal Investigator: Oral B Ospanov, Prof. Corporate fund "University Medical Center" (UMC)

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Oral Ospanov, Professor, University Medical Center, Kazakhstan
ClinicalTrials.gov Identifier: NCT03667469     History of Changes
Other Study ID Numbers: UMC
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Oral Ospanov, University Medical Center, Kazakhstan:
Obesity
Bariatric surgery
Ospanov's procedure
Gastric bypass
Band-separated gastric bypass
Weight loss therapy
Metabolic syndrom
Life expectancy
Telomere lenght
Hypocaloric diet
Additional relevant MeSH terms:
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Metabolic Syndrome
Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases