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Laparascopic Sleeve Gastrectomy vs. Endoscopic Gastric Plication in Obesity

NCT ID: NCT05259644

Last Updated: 2022-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-28

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Bariatric surgery is the most efficacious treatment of obesity and type 2 diabetes mellitus. Novel endoscopic methods based on the principles of bariatric surgery are also highly effective. No direct randomized comparison of both types of treatment has been performed to date and the mechanisms of action of both procedures are still only partially clarified. The aim of the project is to perform a randomized trial comparing efficacy and safety of three treatment options in patients with obesity: laparoscopic sleeve gastrectomy, endoscopic gastric plication and conservative treatment. A further aim is to characterize the influence of the three treatments on subclinical inflammation, gut microbiota composition and changes of gastrointestinal hormones. The results of the project will describe the efficacy and safety of these 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.

Conditions

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Obesity

Keywords

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Obesity Diabetes mellitus Endoscopy Surgery Gut microbiota

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

In total 75 patients will be randomized into 3 groups.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Conservative treatment group

Obese patients treated with conservative approach - diet.

Group Type ACTIVE_COMPARATOR

conservative treatment of obesity

Intervention Type OTHER

Diet and exercise

Laparoscopic sleeve gastrectomy

Obese patients treated with laparoscopic sleeve gastrectomy.

Group Type ACTIVE_COMPARATOR

laparoscopic sleeve gastrectomy

Intervention Type DEVICE

Surgical procedure - laparoscopic sleeve gastrectomy.

endoscopic gastric plication

Obese patients treated with endoscopic gastric plication.

Group Type ACTIVE_COMPARATOR

endoscopic gastric plication

Intervention Type DEVICE

Endoscopic procedure - endoscopic gastric plication

Interventions

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laparoscopic sleeve gastrectomy

Surgical procedure - laparoscopic sleeve gastrectomy.

Intervention Type DEVICE

conservative treatment of obesity

Diet and exercise

Intervention Type OTHER

endoscopic gastric plication

Endoscopic procedure - endoscopic gastric plication

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Other diabetes mellitus types (type 1 DM, monogenic DM, secondary DM)
2. Prior gastrointestinal (GIT) surgery interfering with study procedure
3. Severe gastroesophageal reflux, severe GIT motility disorder
4. Active malignancy
5. Acute myocardial infarction, unstable angina pectoris, acute stroke 3 months prior to enrolment
6. 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

6\. 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute for Clinical and Experimental Medicine

OTHER_GOV

Sponsor Role lead

Responsible Party

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Julius Spicak

prof. MUDr. Julius Spicak, CSc.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Institute for Clinical and Experimental Medicine

Prague, , Czechia

Site Status

Countries

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Czechia

Central Contacts

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Jan Kral, MD

Role: CONTACT

Phone: +420236053280

Email: [email protected]

Even Machytka, MD

Role: CONTACT

Phone: +420236053280

Email: [email protected]

Other Identifiers

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NU21-01-00096

Identifier Type: -

Identifier Source: org_study_id