NCT05259644

Brief Summary

The project will describe the efficacy and safety of laparoscopic sleeve gastrectomy and endoscopic gastric plication procedures as compared to conservative therapy and clarify the mechanisms of action of these treatments. The project will also contribute to more precise indications of bariatric or endoscopic methods in clinical practice and enable personalized choice of therapy for particular patient.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 11, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 28, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 28, 2022

Status Verified

February 1, 2022

Enrollment Period

2.2 years

First QC Date

January 11, 2022

Last Update Submit

February 17, 2022

Conditions

Obesity

Keywords

ObesityDiabetes mellitusEndoscopySurgeryGut microbiota

Outcome Measures

Primary Outcomes (1)

  • Change in Body Weight

    To compare the change in body weight after laparoscopic sleeve gastrectomy ve. endoscopic gastric plication and endoscopic gastric plication vs. conservative treatment of obesity

    6 months

Secondary Outcomes (3)

  • Change in Glycated Hemoglobin

    6 months

  • Change in serum glucagon-like peptide 1 (GLP-1)

    6 months

  • Change in fasting blood glucose

    6 months

Other Outcomes (3)

  • Change in hsCRP

    6 months

  • Rehospitalizations

    6 months

  • Change in the IWQOL (The Impact of Weight on Quality of Life) questionnaire

    6 months

Study Arms (3)

Conservative treatment group

ACTIVE COMPARATOR

Obese patients treated with conservative approach - diet.

Other: conservative treatment of obesity

Laparoscopic sleeve gastrectomy

ACTIVE COMPARATOR

Obese patients treated with laparoscopic sleeve gastrectomy.

Device: laparoscopic sleeve gastrectomy

endoscopic gastric plication

ACTIVE COMPARATOR

Obese patients treated with endoscopic gastric plication.

Device: endoscopic gastric plication

Interventions

laparoscopic sleeve gastrectomyDEVICE

Surgical procedure - laparoscopic sleeve gastrectomy.

Laparoscopic sleeve gastrectomy
conservative treatment of obesityOTHER

Diet and exercise

Conservative treatment group
endoscopic gastric plicationDEVICE

Endoscopic procedure - endoscopic gastric plication

endoscopic gastric plication

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • BMI \> 35 kg/m2
  • For patients with type 2 diabetes - stable antidiabetic medication \> 1 month
  • Age 18-60 years

You may not qualify if:

  • Other diabetes mellitus types (type 1 DM, monogenic DM, secondary DM)
  • Prior gastrointestinal (GIT) surgery interfering with study procedure
  • Severe gastroesophageal reflux, severe GIT motility disorder
  • Active malignancy
  • Acute myocardial infarction, unstable angina pectoris, acute stroke 3 months prior to enrolment
  • Acute liver or kidney failure
  • Transplantation of insulin producing tissue
  • Gravidity or lactation
  • Mental disorder
  • Inability to sign informed consent
  • Any other contraindication of bariatric surgery or bariatric endoscopy procedure
  • \. Acute liver or kidney failure 7. Transplantation of insulin producing tissue 8. Gravidity or lactation 9. Mental disorder 10. Inability to sign informed consent 11. Any other contraindication of bariatric surgery or bariatric endoscopy procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Clinical and Experimental Medicine

Prague, 14021, Czechia

Location

MeSH Terms

Conditions

ObesityDiabetes Mellitus

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Central Study Contacts

Jan Kral, MD

CONTACT

+420236053280jan.kral@ikem.cz

Even Machytka, MD

CONTACT

+420236053280even.machytka@ikem.cz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: In total 75 patients will be randomized into 3 groups.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. MUDr. Julius Spicak, CSc.

Study Record Dates

First Submitted

January 11, 2022

First Posted

February 28, 2022

Study Start

February 1, 2022

Primary Completion

May 1, 2024

Study Completion

December 31, 2024

Last Updated

February 28, 2022

Record last verified: 2022-02

Locations

CZ(1)