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Type 2 Diabetes MellitusEarly Phase 1NCT02287285

Determinants of Diabetes Remission After Gastric Bypass Surgery

A Early Phase 1 study testing Exendin9 in people with Type 2 Diabetes Mellitus, run by Blandine Laferrere at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Longitudinal study of beta cell function up to 2 years after GBP surgery. Evaluation of the role of endogenous glucagon-like peptide-1 (GLP-1). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Exendin9
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
Oct 2014to Jul 2019
Phase
Early Phase 1
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with a wide range of T2DM (duration, treatment modalities and control, in or not in remission) and scheduled for GBP surgery
  • Blood pressure is under at least moderate control <160/100 mmHg
  • Patients can be on dyslipidemia medications but need fasting triglyceride < 600 mg/dl
  • Patients without recent (last 6 months) history of cardiovascular disease (CVD)
  • BMI > 35 and < 55 kg/m2 prior to GBP surgery

Who cannot join

  • Active cancer
  • Unstable angina
  • Recent stroke
  • Current therapy that may affect glucose metabolism such as glucocorticoids, HIV medications, etc
  • Active infection
  • Kidney failure
Show all 12Show fewer
  • Severe liver dysfunction
  • Severe respiratory or cardiac failure
  • History of allergic reaction to exendin 9-39
  • History of pancreatitis, history of cholelithiasis, history of alcoholism
  • Presence of high triglyceride levels (>600 ng/dl)
  • Pregnancy (a pregnancy test will be done prior to enrollment and prior to each procedure in all premenopausal women)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • New York Obesity Research Center, Columbia University

    New York, New York, 10032

Other trials in United States

About this study

Official title: Long Term Change of GLP-1 Insulinotropic Effect After GBP Surgery

Longitudinal study of beta cell function up to 2 years after GBP surgery. Evaluation of the role of endogenous glucagon-like peptide-1 (GLP-1).

Read the detailed description

The increased prevalence of obesity and type 2 diabetes (T2DM) has resulted in a surge in the number of patients seeking surgical weight loss. Gastric bypass surgery (GBP) results in 30-40% body weight loss with resolution of T2DM in 40-80% of cases. The mechanisms by which T2DM improves after GBP are unclear. Glycemic control occurs long before significant weight loss, suggesting that the nature of the procedure, rather than the weight loss, is responsible for the T2DM improvement. Recent data have singled out the role of the gut hormones known as incretins in diabetes improvement after GBP. The current proposal will study 1) whether the short and long term change in the gut hormone incretins after GBP results in improved insulin secretion in response to the administration of oral and IV glucose, in patients with diabetes undergoing GBP surgery; 2) the factors responsible for diabetes remission - or lack of - after GBP. The investigators wish to apply our finding to define better surgical outcome on diabetes.

Being tested
Exendin9
Keywords
Type 2 Diabetes Mellitus, Gastric Bypass Surgery, Exendin9
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exendin9Drug

    Also called Exendin(9-39)

    Dosed at 600 pmol/kg/min for 210 minutes.

Study groups in NCT02287285
Study groupRoleWhat they receive
Exendin9ExperimentalLongitudinal study of insulin secretion and sensitivity in patients with type 2 diabetes before and after gastric bypass surgery.
Receives: Drug: Exendin9

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Beta Cell Sensitivity (BCS)

    Oral glucose tolerance test (OGTT) will be used to calculate BCS Graded glucose infusion with arginine (GGI) will be used to calculate BCS

    Measured: at 2 years post GBP surgery

Secondary outcomes (3)

  1. Insulin Secretion Rate (ISR) after OGTT

    An oral glucose tolerance test (OGTT) will be used to estimate ISR in subjects before and up to 2 years after GBP

    Measured: 2 years post GBP surgery

  2. Insulin Secretion Rate (ISR) after GGI

    A graded glucose infusion with arginine (GGI) will be used to estimate ISR in subjects before and up to 2 years after GBP

    Measured: 2 years post GBP surgery

  3. Maximal Beta Cell Function

    The effect of a graded glucose infusion with arginine (GGI) on insulin secretion rate (ISR) will be measured in subjects before and up to 2 years after GBP

    Measured: 2 years post GBP surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionAug 2017
  4. Study completionJul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02287285
Sponsor's protocol ID
AAAO1360
Other IDs
1R01DK098056-01A1, 1F32DK113747-01A1
Status last verified
Apr 2020
First submitted
10 Oct 2014
Last updated
24 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data generated from this study will be presented at national or international conferences and published in a timely fashion. All final peer-reviewed manuscripts that arise from this study will be submitted upon acceptance for publication to the digital archive NIH National Library of Medicine PubMed Central (PMC) database, according to the NIH Policy on Enhancing Public Access to Archived Publications Resulting from NIH Funded Research. Any data released for publication will be for research purposes only and will not include identifiable data on any of the participants.

Publications

  • Prasad M, Mark V, Ligon C, Dutia R, Nair N, Shah A, Laferrere B. Role of the Gut in the Temporal Changes of beta-Cell Function After Gastric Bypass in Individuals With and Without Diabetes Remission. Diabetes Care. 2022 Feb 1;45(2):469-476. doi: 10.2337/dc21-1270.

    PubMed 34857533

  • Shah A, Holter MM, Rimawi F, Mark V, Dutia R, McGinty J, Levin B, Laferrere B. Insulin Clearance After Oral and Intravenous Glucose Following Gastric Bypass and Gastric Banding Weight Loss. Diabetes Care. 2019 Feb;42(2):311-317. doi: 10.2337/dc18-1036. Epub 2018 Dec 6.

    PubMed 30523032

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Exendin9 in people with Type 2 Diabetes Mellitus, run by Blandine Laferrere 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 5 inclusion and 12 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 24 Apr 2020. 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Beta Cell Sensitivity (BCS) (time frame: at 2 years post GBP surgery). 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 NCT02287285, which also lists 2 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 24 Apr 2020.

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