NCT05854875

Brief Summary

The goal of this randomized clinical trial is to evaluate glycemic control in patients with morbid obesity and type 2 diabetes after Roux-en-Y gastric bypass (RYGBP) and RYGBP with fundus resection. The main questions to answer are:

  • Rate of diabetes remission and the role of the gastrointestinal hormones
  • Whether fundus resection leads to improved glycemic control Patients will randomly undergo typical RYGBP or RYGBP with fundus resection. Gastrointestinal hormones profile \[ghrelin, glucagon-like peptide-1 (GLP-1), peptide YY (PYY), glucagon\], glucose levels and insulin response will be measured preoperatively, at 6 months and at 12 months, during 120-min OGTT.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable type-2-diabetes

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

September 22, 2019

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2023

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 11, 2023

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

3.4 years

First QC Date

April 21, 2023

Last Update Submit

May 2, 2023

Conditions

Type 2 DiabetesMorbid ObesityBariatric Surgery

Keywords

Gastric FundusGastrointestinal Hormones

Outcome Measures

Primary Outcomes (8)

  • Diabetes remission in both groups

    Change in HbA1c levels

    At 6 months and 12 months postoperatively

  • Change in fasting and postprandial glucose levels

    Glucose levels (mg/dl)

    At 6 months and 12 months postoperatively

  • Change in insulin levels, fasting and postprandial

    Insulin levels (μIU/ml)

    At 6 months and 12 months postoperatively

  • Change in HOMA - IR

    HOMA IR calculation with glucose (mg/dl) and insulin (mU/L)

    At 6 months and 12 months postoperatively

  • Change in ghrelin levels

    Fasting and postprandial ghrelin levels (pg/ml)

    At 6 months and 12 months postoperatively

  • Change in GLP-1 levels

    Fasting and postprandial GLP-1 levels (pg/ml)

    At 6 months and 12 months postoperatively

  • Change in PYY levels

    Fasting and postprandial PYY levels (ng/ml)

    At 6 months and 12 months postoperatively

  • Change in glucagon levels

    Fasting and postprandial glucagon levels (pg/ml)

    At 6 months and 12 months postoperatively

Study Arms (2)

RYGBP

ACTIVE COMPARATOR

Laparoscopic Roux en Y Gastric Bypass

Procedure: Laparoscopic Roux en Y gastric bypass

RYGBP + FR

EXPERIMENTAL

Laparoscopic Roux en Y Gastric Bypass with fundus resection

Procedure: Laparoscopic Roux en Y gastric bypass with fundus resection

Interventions

Laparoscopic Roux en Y gastric bypassPROCEDURE

Laparoscopic RYGBP included the creation of a small gastric pouch, with a 200cm biliopancreatic limb and a 150cm alimentary limb.

RYGBP
Laparoscopic Roux en Y gastric bypass with fundus resectionPROCEDURE

Laparoscopic RYGBP included the creation of a small gastric pouch, with a 200cm biliopancreatic limb and a 150cm alimentary limb. Fundus resection is further applied in this arm.

RYGBP + FR

Eligibility Criteria

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

You may qualify if:

  • morbid obesity (ΒΜΙ ≥ 40)
  • type II diabetes mellitus (T2DM)
  • duration of T2DM shorter than 8 years

You may not qualify if:

  • pregnancy
  • type 1 diabetes
  • previous gastrointestinal surgeries
  • alcohol consumption
  • depression
  • no compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Patras, University Hospital of Patras

Pátrai, Rio, 26504, Greece

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Obesity, Morbid

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesObesityOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 21, 2023

First Posted

May 11, 2023

Study Start

September 22, 2019

Primary Completion

March 2, 2023

Study Completion

April 10, 2023

Last Updated

May 11, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)