NCT03667469

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 24, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 12, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2020

Completed
Last Updated

April 15, 2020

Status Verified

April 1, 2020

Enrollment Period

1.9 years

First QC Date

August 31, 2018

Last Update Submit

April 13, 2020

Conditions

Obesity

Keywords

ObesityBariatric surgeryOspanov's procedureOne anastomosis gastric bypassStapleless - separated gastric bypassWeight loss therapyMetabolic syndromeLife expectancyTelomere lenghtHypocaloric diet

Outcome Measures

Primary Outcomes (1)

  • Change of body mass index

    The measure is assessing a change of body mass index. Weight (kg) and height (cm) will be combined with the report of measurement by body mass index (BMI) kg/m2.

    Baseline, at 12 months after surgery

Secondary Outcomes (3)

  • Changes of comorbidities

    Baseline, at 12 months after surgery

  • Changes in the length of leukocyte telomere

    Baseline, at 12 months after surgery

  • Change of Quality of life

    at 12 months after surgery

Study Arms (3)

Stapleless one anastomosis gastric bypass

EXPERIMENTAL

Laparoscopic stapleless-separated one anastomosis (mini-) gastric bypass procedures

Procedure: Laparoscopic one anastomosis gastric bypass

Staple use mini-gastric bypass

ACTIVE COMPARATOR

Laparoscopic stapler-separated one anastomosis (mini-) gastric bypass procedures

Procedure: Laparoscopic one anastomosis gastric bypass

Hypocaloric diet therapy

ACTIVE COMPARATOR

Hypocaloric diet therapy with energy restriction (-500 kcal/d)

Dietary Supplement: Hypocaloric diet therapy

Interventions

Laparoscopic one anastomosis gastric bypassPROCEDURE

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.

Also known as: MGB/OAGB, mini-gastric bypass
Staple use mini-gastric bypassStapleless one anastomosis gastric bypass
Hypocaloric diet therapyDIETARY_SUPPLEMENT

Hypocaloric diet therapy with energy restriction (-500 kcal/d)

Hypocaloric diet therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 12 months and the possibility of follow up;
  • Informed written consent of the patient for randomization and treatment.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Scientific Center for Oncology and Transplantation

Astana, 010000, Kazakhstan

Location

Related Publications (3)

  • Ospanov OB. Laparoscopic Band-Separated One Anastomosis Gastric Bypass. Obes Surg. 2016 Sep;26(9):2268-2269. doi: 10.1007/s11695-016-2281-2.

    PMID: 27384682RESULT

  • Ospanov O, Akilzhanova A, Buchwald JN, Fursov A, Bekmurzinova F, Rakhimova S, Yeleuov G, Kozhamkulov U, Abdina Z, Fursov R, Jumayeva L. Stapleless vs Stapled Gastric Bypass vs Hypocaloric Diet: a Three-Arm Randomized Controlled Trial of Body Mass Evolution with Secondary Outcomes for Telomere Length and Metabolic Syndrome Changes. Obes Surg. 2021 Jul;31(7):3165-3176. doi: 10.1007/s11695-021-05454-2. Epub 2021 May 8.

    PMID: 33963974DERIVED

  • Ospanov O, Yeleuov G, Kadyrova I, Bekmurzinova F. The life expectancy of patients with metabolic syndrome after weight loss: study protocol for a randomized clinical trial (LIFEXPE-RT). Trials. 2019 Apr 8;20(1):202. doi: 10.1186/s13063-019-3304-9.

    PMID: 30961631DERIVED

MeSH Terms

Conditions

ObesityMetabolic Syndrome

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Oral B Ospanov, Prof.

    Corporate fund "University Medical Center" (UMC)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
sealed non-transparent envelopes
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are randomly allocated to one of three groups: 1. Surgical bariatric procedure in the first (A) group undergo the laparoscopic stapleless-separated mini-gastric bypass procedure: Gastric band (absorbable ligature) was introduced in the abdomen and retracted through the retrogastric tunnel. Mobilization and displacement of gastric fundus and create obstructive gastroplication. Hand-sewn gastrojejunostomy completes the intervention. 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 31, 2018

First Posted

September 12, 2018

Study Start

May 24, 2018

Primary Completion

April 10, 2020

Study Completion

April 10, 2020

Last Updated

April 15, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

KA(1)