Gastric Bypass SurgeryNCT00571220
Mechanisms of Diabetes Control After Weight Loss Surgery
An observational study of Gastric Bypass Surgery and Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Obesity and type 2 diabetes (T2DM) are increasing in the US. One third of patients seeking bariatric surgery have T2DM. Although all surgeries result in significant weight loss and often 'cure' the T2DM, the rapid onset and the magnitude of the benefits of gastric bypass (GBP) on T2DM has thus far baffled clinical… Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Gastric Bypass Surgery, Obesity
- What is being tested?
- gastric bypass surgery and Diet induced weight loss
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Dec 2010
- Phase
- Observational
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Morbidly obese patients with type 2 diabetes of less than 5 years duration
Who may be able to join
- morbidly obese with type 2 diabetes candidates and being evaluated at our institution for bariatric surgery (group1); morbidly obese patients with type 2 diabetes who want to lose weight by diet.
Who cannot join
- any condition that would be contra-indicated for bariatric surgery (ex:unstable angina)
- diabetes treated by insulin, thiazolidinediones (TZD), exenatide, DPP-IV inhibitors
- HbA1C > 8%
Trial locations and contacts
1 site in 1 country.
United States1 site
St Luke's Roosevelt Hospital Center
New York, New York, 10025
About this study
Obesity and type 2 diabetes (T2DM) are increasing in the US. One third of patients seeking bariatric surgery have T2DM. Although all surgeries result in significant weight loss and often 'cure' the T2DM, the rapid onset and the magnitude of the benefits of gastric bypass (GBP) on T2DM has thus far baffled clinical scientists. Limited data suggest that the improvement in T2DM after GBP occurs very rapidly, and may not be wholly accounted for by weight loss. Secretion of incretins (gut peptides secreted in response to meals which enhance insulin secretion) is impaired in T2DM and improves after GBP, possibly due to the specific anatomical changes after this surgery. While some determinants of impaired insulin secretion, such as glucotoxicity, improve equally after diet or surgical weight loss, the improvement in the incretin effect after GBP might be specific to this surgery. The aim of this study is to determine whether the magnitude of the incretin effect on insulin secretion is greater after GBP than after an equivalent diet-induced weight loss. We will compare, in obese patients with diabetes, randomized to very low calorie diet or to GBP, the effect of an equivalent weight loss on the incretin effect (difference in insulin secretion after comparable oral and intravenous (IV) glucose loads). As more obese diabetic patients undergo GBP, understanding the mechanisms that produce improvement in their diabetes is increasingly important.
- Conditions
- Gastric Bypass Surgery, Obesity
- Being tested
- gastric bypass surgery, Diet induced weight loss
- Keywords
- gastric bypass, diabetes, obesity, diet-induced weight loss, incretin levels (GLP-1,GIP), incretin effect
- Medical subject headings
- Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastric bypass surgeryProcedure or surgery
weight loss bariatric surgery
Diet induced weight lossOther
low calorie diet with meal replacements. weekly outpatient visits with nutritionist.
| Study group | Role | What they receive |
|---|---|---|
| Gastric bypass surgery | Surgical group of obese patients with type 2 diabetes undergoing gastric bypass surgery Receives: Procedure: gastric bypass surgery | |
| Diet induced weight loss | Diet group of obese patient with type 2 diabetes, matched with the surgical group for diabetes duration, diabetes control (HbA1C), BMI, age. Receives: Other: Diet induced weight loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in incretin
Change in incretin (gastric inhibitory peptide [GIP] and glucagon-like peptide-1 [GLP-1])
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2007 (estimated)
- Study startSep 2005
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastric Bypass SurgeryStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Blandine Laferrere, MD, Principal investigator, St. Luke's-Roosevelt Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00571220
- Sponsor's protocol ID
- DK67561 (completed)
- Other IDs
- R01DK067561
- Status last verified
- Mar 2018
- First submitted
- 7 Dec 2007
- Last updated
- 9 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Laferrere B, Heshka S, Wang K, Khan Y, McGinty J, Teixeira J, Hart AB, Olivan B. Incretin levels and effect are markedly enhanced 1 month after Roux-en-Y gastric bypass surgery in obese patients with type 2 diabetes. Diabetes Care. 2007 Jul;30(7):1709-16. doi: 10.2337/dc06-1549. Epub 2007 Apr 6.
PubMed 17416796Dutia R, Brakoniecki K, Bunker P, Paultre F, Homel P, Carpentier AC, McGinty J, Laferrere B. Limited recovery of beta-cell function after gastric bypass despite clinical diabetes remission. Diabetes. 2014 Apr;63(4):1214-23. doi: 10.2337/db13-1176. Epub 2013 Dec 2.
PubMed 24296713Laferrere B, Swerdlow N, Bawa B, Arias S, Bose M, Olivan B, Teixeira J, McGinty J, Rother KI. Rise of oxyntomodulin in response to oral glucose after gastric bypass surgery in patients with type 2 diabetes. J Clin Endocrinol Metab. 2010 Aug;95(8):4072-6. doi: 10.1210/jc.2009-2767. Epub 2010 May 25.
PubMed 20501690
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Diabetes Control After Weight Loss Surgery
- ClinicalTrials.gov ID
- NCT00571220
- Acronym / sponsor ID
- DK67561 (completed)
- Conditions
- Gastric Bypass Surgery, Obesity
- Keywords
- gastric bypass, diabetes, obesity, diet-induced weight loss, incretin levels (GLP-1,GIP), incretin effect
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Sep 2005 (actual)
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 11 Dec 2007 (estimated)
- 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.
Obesity and type 2 diabetes (T2DM) are increasing in the US. One third of patients seeking bariatric surgery have T2DM. Although all surgeries result in significant weight loss and often 'cure' the T2DM, the rapid onset and the magnitude of the benefits of gastric bypass (GBP) on T2DM has thus far baffled clinical scientists. Limited data suggest that the improvement in T2DM after GBP occurs very rapidly, and may not be wholly accounted for by weight loss. Secretion of incretins (gut peptides secreted in response to meals which enhance insulin secretion) is impaired in T2DM and improves after GBP, possibly due to the specific anatomical changes after this surgery. While some determinants of impaired insulin secretion, such as glucotoxicity, improve equally after diet or surgical weight loss, the improvement in the incretin effect after GBP might be specific to this surgery. The aim of this study is to determine whether the magnitude of the incretin effect on insulin secretion is greater after GBP than after an equivalent diet-induced weight loss. We will compare, in obese patients with diabetes, randomized to very low calorie diet or to GBP, the effect of an equivalent weight loss on the incretin effect (difference in insulin secretion after comparable oral and intravenous (IV) glucose loads). As more obese diabetic patients undergo GBP, understanding the mechanisms that produce improvement in their diabetes is increasingly important.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastric bypass surgery | – | Procedure: gastric bypass surgerySurgical group of obese patients with type 2 diabetes undergoing gastric bypass surgery |
| Diet induced weight loss | – | Other: Diet induced weight lossDiet group of obese patient with type 2 diabetes, matched with the surgical group for diabetes duration, diabetes control (HbA1C), BMI, age. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Morbidly obese patients with type 2 diabetes of less than 5 years duration
Key inclusion criteria (1 listed)
- morbidly obese with type 2 diabetes candidates and being evaluated at our institution for bariatric surgery (group1); morbidly obese patients with type 2 diabetes who want to lose weight by diet.
Key exclusion criteria (3 listed)
- any condition that would be contra-indicated for bariatric surgery (ex:unstable angina)
- diabetes treated by insulin, thiazolidinediones (TZD), exenatide, DPP-IV inhibitors
- HbA1C > 8%
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 |
|---|---|---|
| gastric bypass surgeryweight loss bariatric surgery | Procedure or surgery | Gastric bypass surgery |
| Diet induced weight losslow calorie diet with meal replacements. weekly outpatient visits with nutritionist. | Other | Diet induced weight loss |
Primary outcome
Change in incretin
Time frame: One month
Change in incretin (gastric inhibitory peptide [GIP] and glucagon-like peptide-1 [GLP-1])
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 9 Mar 2018.
- Results publication: PubMed 17416796Laferrere B, Heshka S, Wang K, Khan Y, McGinty J, Teixeira J, Hart AB, Olivan B. Incretin levels and effect are markedly enhanced 1 month after Roux-en-Y gastric bypass surgery in obese patients with type 2 diabetes. Diabetes Care. 2007 Jul;30(7):1709-16. doi: 10.2337/dc06-1549. Epub 2007 Apr 6.
- Derived from this study: PubMed 24296713Dutia R, Brakoniecki K, Bunker P, Paultre F, Homel P, Carpentier AC, McGinty J, Laferrere B. Limited recovery of beta-cell function after gastric bypass despite clinical diabetes remission. Diabetes. 2014 Apr;63(4):1214-23. doi: 10.2337/db13-1176. Epub 2013 Dec 2.
- Derived from this study: PubMed 20501690Laferrere B, Swerdlow N, Bawa B, Arias S, Bose M, Olivan B, Teixeira J, McGinty J, Rother KI. Rise of oxyntomodulin in response to oral glucose after gastric bypass surgery in patients with type 2 diabetes. J Clin Endocrinol Metab. 2010 Aug;95(8):4072-6. doi: 10.1210/jc.2009-2767. Epub 2010 May 25.
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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.
Blandine Laferrere, MD principal investigator
St. Luke's-Roosevelt Hospital Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Bypass Surgery and Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
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 1 inclusion and 3 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 9 Mar 2018. 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 United States. 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?
Change in incretin (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00571220, which also lists 3 linked publications.
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 9 Mar 2018.