NCT04812132

Brief Summary

A prospective multicenter randomized controlled trial to compare the outcomes of one-anastomosis gastric bypass to long biliary limb Roux gastric bypass. We plan to enroll up to 500 patients from three different clinics in Estonia. Outcomes are excess weight loss %, impact on type 2 diabetes, hypertension, hyperlipidemia and obstructive sleep apnea. Other outcomes are nutritional deficiencies, occurrence of reflux disease and impact on quality of life. There are planned outpatient visits 1, 5 and 10 years after the surgery to measure the impacts. There are a lot of studies comparing OAGB to standard Roux gastric bypass but non comparing it to long biliary limb gastric bypass.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable obesity

Timeline
130mo left

Started Jan 2021

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress33%
Jan 2021Dec 2036

Study Start

First participant enrolled

January 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 23, 2021

Completed
10.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2031

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2036

Last Updated

March 23, 2021

Status Verified

March 1, 2021

Enrollment Period

11 years

First QC Date

February 27, 2021

Last Update Submit

March 21, 2021

Conditions

Obesity

Keywords

OAGBLong biliary limb Roux gastric bypassMetabolic surgeryObesity

Outcome Measures

Primary Outcomes (9)

  • Excess weight loss %

    Calculated loss of the excess weight

    10 years

  • Impact on type 2 diabetes mellitus

    Outcome of type 2 diabetes mellitus after the surgery, measured in change in HbA1c %

    10 years

  • Impact on type 2 diabetes mellitus

    Outcome of type 2 diabetes mellitus after the surgery, measured in usage of medication (same dosage, decreased dosage, insulin to peroral, ended all medication)

    10 years

  • Impact on hypertensive disease

    Outcome of hypertensive disease after the surgery; measured in antihypertensive drug usage (same, decrease, ended)

    10 years

  • Impact on total cholesterol

    Outcome of hyperlipidemias after the surgery, measured in change in levels of total cholesterol (mmol/L).

    10 years

  • Impact on hyperlipidemia

    Outcome of hyperlipidemias after the surgery, measured in change in levels of HDL (mmol/L)

    10 years

  • Impact on hyperlipidemia

    Outcome of hyperlipidemias after the surgery, measured in change in levels of LDL (mmol/L)

    10 years

  • Impact on hyperlipidemia

    Outcome of hyperlipidemias after the surgery, measured in change in levels of triglycerides (mmol/L)

    10 years

  • Impact on hyperlipidemias

    Outcome of hyperlipidemias after the surgery, measured in change in levels of total cholesterol, HDL,LDL and triglycerides

    10 years

Secondary Outcomes (3)

  • Nutritional deficiencies: anemia

    10 years

  • Nutritional deficiencies

    10 years

  • GERD

    10 years

Study Arms (2)

Women

ACTIVE COMPARATOR
Procedure: One-anastomosis gastric bypassProcedure: Long biliary limb Roux gastric bypass

Men

ACTIVE COMPARATOR
Procedure: One-anastomosis gastric bypassProcedure: Long biliary limb Roux gastric bypass

Interventions

One-anastomosis gastric bypassPROCEDURE

One group is planned to have one-anastomosis gastric bypass (also known as mini-bypass)

MenWomen
Long biliary limb Roux gastric bypassPROCEDURE

Other group is planned to receive a long biliary limb Roux gastric bypass

MenWomen

Eligibility Criteria

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

You may qualify if:

  • BMI over 35 and obesity related disease
  • BMI over 40
  • age between 18-60 years
  • agrees to participate in the study

You may not qualify if:

  • age under 18 years or over 60 years
  • abundant adhesions discovered during the surgery
  • active upper gastrointestinal ulcer disease
  • prior bariatric surgery
  • active symptomatic reflux disease
  • active psychiatric disease (eg psychosis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tartu University Hospital

Tartu, 50406, Estonia

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor and Teaching staff

Study Record Dates

First Submitted

February 27, 2021

First Posted

March 23, 2021

Study Start

January 1, 2021

Primary Completion (Estimated)

December 31, 2031

Study Completion (Estimated)

December 31, 2036

Last Updated

March 23, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)