Diabetes Remission After RYGBP and RYGBP With Fundus Resection

RYGBP vs RYGBP With Fundus Resection for Morbid Obese Patients With Type 2 Diabetes. Evaluation of the Gastric Fundus in Glycemic Control. A Randomized Clinical Trial.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05854875

Enrollment

Registered

2023-05-11

Start date

2019-09-22

Completion date

2023-04-10

Last updated

2023-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery, Morbid Obesity, Type 2 Diabetes

Keywords

Gastric Fundus, Gastrointestinal Hormones

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.

Interventions

PROCEDURELaparoscopic Roux en Y gastric bypass

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

PROCEDURELaparoscopic Roux en Y gastric bypass with fundus resection

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Diabetes remission in both groups	At 6 months and 12 months postoperatively	Change in HbA1c levels
Change in fasting and postprandial glucose levels	At 6 months and 12 months postoperatively	Glucose levels (mg/dl)
Change in insulin levels, fasting and postprandial	At 6 months and 12 months postoperatively	Insulin levels (μIU/ml)
Change in HOMA - IR	At 6 months and 12 months postoperatively	HOMA IR calculation with glucose (mg/dl) and insulin (mU/L)
Change in ghrelin levels	At 6 months and 12 months postoperatively	Fasting and postprandial ghrelin levels (pg/ml)
Change in GLP-1 levels	At 6 months and 12 months postoperatively	Fasting and postprandial GLP-1 levels (pg/ml)
Change in PYY levels	At 6 months and 12 months postoperatively	Fasting and postprandial PYY levels (ng/ml)
Change in glucagon levels	At 6 months and 12 months postoperatively	Fasting and postprandial glucagon levels (pg/ml)

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026