Type 2 DiabetesNCT05854875
Diabetes Remission After RYGBP and RYGBP With Fundus Resection
A study testing Laparoscopic Roux en Y gastric bypass and Laparoscopic Roux en Y gastric bypass with fundus resection in people with Type 2 Diabetes and Morbid Obesity, run by University of Patras at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Type 2 Diabetes, Morbid Obesity, Bariatric Surgery
- What is being tested?
- Laparoscopic Roux en Y gastric bypass and Laparoscopic Roux en Y gastric bypass with fundus resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGreece
- Study dates
- 22 Sep 2019to 10 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- morbid obesity (ΒΜΙ ≥ 40)
- type II diabetes mellitus (T2DM)
- duration of T2DM shorter than 8 years
Who cannot join
- pregnancy
- type 1 diabetes
- previous gastrointestinal surgeries
- alcohol consumption
- depression
- no compliance
Trial locations and contacts
1 site in 1 country.
Greece1 site
University of Patras, University Hospital of Patras
Pátrai, Rio, 26504
About this study
Official title: 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.
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.
- Conditions
- Type 2 Diabetes, Morbid Obesity, Bariatric Surgery
- Being tested
- Laparoscopic Roux en Y gastric bypass, Laparoscopic Roux en Y gastric bypass with fundus resection
- Keywords
- Gastric Fundus, Gastrointestinal Hormones
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Roux en Y gastric bypassProcedure or surgery
Laparoscopic RYGBP included the creation of a small gastric pouch, with a 200cm biliopancreatic limb and a 150cm alimentary limb.
Laparoscopic Roux en Y gastric bypass with fundus resectionProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| RYGBP | Active comparator | Laparoscopic Roux en Y Gastric Bypass Receives: Procedure: Laparoscopic Roux en Y gastric bypass |
| RYGBP + FR | Experimental | Laparoscopic Roux en Y Gastric Bypass with fundus resection Receives: Procedure: Laparoscopic Roux en Y gastric bypass with fundus resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes remission in both groups
Change in HbA1c levels
Measured: At 6 months and 12 months postoperatively
Change in fasting and postprandial glucose levels
Glucose levels (mg/dl)
Measured: At 6 months and 12 months postoperatively
Change in insulin levels, fasting and postprandial
Insulin levels (μIU/ml)
Measured: At 6 months and 12 months postoperatively
Change in HOMA - IR
HOMA IR calculation with glucose (mg/dl) and insulin (mU/L)
Measured: At 6 months and 12 months postoperatively
Change in ghrelin levels
Fasting and postprandial ghrelin levels (pg/ml)
Measured: At 6 months and 12 months postoperatively
Change in GLP-1 levels
Fasting and postprandial GLP-1 levels (pg/ml)
Measured: At 6 months and 12 months postoperatively
Change in PYY levels
Fasting and postprandial PYY levels (ng/ml)
Measured: At 6 months and 12 months postoperatively
Change in glucagon levels
Fasting and postprandial glucagon levels (pg/ml)
Measured: At 6 months and 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start22 Sep 2019
- Primary completion2 Mar 2023
- Study completion10 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitrios Kehagias, University of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854875
- Sponsor's protocol ID
- 5378/35835
- Status last verified
- May 2023
- First submitted
- 21 Apr 2023
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05854875
- Acronym / sponsor ID
- 5378/35835
- Conditions
- Type 2 Diabetes, Morbid Obesity, Bariatric Surgery
- Keywords
- Gastric Fundus, Gastrointestinal Hormones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of PatrasUniversity, hospital or other
- Study start
- 22 Sep 2019 (actual)
- Primary completion
- 2 Mar 2023 (actual)
- Study completion
- 10 Apr 2023 (actual)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RYGBP | Active comparator | Procedure: Laparoscopic Roux en Y gastric bypassLaparoscopic Roux en Y Gastric Bypass |
| RYGBP + FR | Experimental | Procedure: Laparoscopic Roux en Y gastric bypass with fundus resectionLaparoscopic Roux en Y Gastric Bypass with fundus resection |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- morbid obesity (ΒΜΙ ≥ 40)
- type II diabetes mellitus (T2DM)
- duration of T2DM shorter than 8 years
Key exclusion criteria (6 listed)
- pregnancy
- type 1 diabetes
- previous gastrointestinal surgeries
- alcohol consumption
- depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic Roux en Y gastric bypassLaparoscopic RYGBP included the creation of a small gastric pouch, with a 200cm biliopancreatic limb and a 150cm alimentary limb. | Procedure or surgery | RYGBP |
| Laparoscopic Roux en Y gastric bypass with fundus resectionLaparoscopic 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. | Procedure or surgery | RYGBP + FR |
Primary outcome
Diabetes remission in both groups
Time frame: At 6 months and 12 months postoperatively
Change in HbA1c levels
Change in fasting and postprandial glucose levels
Time frame: At 6 months and 12 months postoperatively
Glucose levels (mg/dl)
Change in insulin levels, fasting and postprandial
Time frame: At 6 months and 12 months postoperatively
Insulin levels (μIU/ml)
Change in HOMA - IR
Time frame: At 6 months and 12 months postoperatively
HOMA IR calculation with glucose (mg/dl) and insulin (mU/L)
Change in ghrelin levels
Time frame: At 6 months and 12 months postoperatively
Fasting and postprandial ghrelin levels (pg/ml)
Change in GLP-1 levels
Time frame: At 6 months and 12 months postoperatively
Fasting and postprandial GLP-1 levels (pg/ml)
Change in PYY levels
Time frame: At 6 months and 12 months postoperatively
Fasting and postprandial PYY levels (ng/ml)
Change in glucagon levels
Time frame: At 6 months and 12 months postoperatively
Fasting and postprandial glucagon levels (pg/ml)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Roux en Y gastric bypass and Laparoscopic Roux en Y gastric bypass with fundus resection in people with Type 2 Diabetes and Morbid Obesity, run by University of Patras at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes remission in both groups (time frame: At 6 months and 12 months postoperatively). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.