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Bypass, GastricPhase 1NCT02204813

To Define the Role of GLP-1 for Improving Glucose Homeostasis in Humans Following Gastric Bypass Surgery

A Phase 1 study testing Lo-Xenin, Hi-Xenin and Extra Hi-Xenin in people with Bypass, Gastric and Roux-en-Y Gastric Bypass, run by Washington University School of Medicine 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

There is a marked and long-lasting improvement in glucose homeostasis that follows Roux-en-y gastric bypass surgery (RYGB) in humans. This improvement has been attributed in large part to an intestinal hormone, called GLP-1, that is released into the circulation immediately after eating. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Lo-Xenin, Hi-Xenin and Extra Hi-Xenin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
13 participants
Where
1 siteUnited States
Study dates
Jul 2014to 17 Nov 2015
Phase
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

  • Individuals must be able to consent for their own participation (no mental impairment affecting cognition or willingness to follow study instructions).
  • Healthy, weight stable, with previous Roux-en-Y gastric bypass surgery and no clinical evidence of type 2 diabetes either before and after Roux-en-Y gastric bypass surgery.
  • Women of childbearing potential must be currently taking/using a method of birth control that is acceptable to the investigators. A pregnancy test will be done at the beginning of each visit. Any woman with a positive pregnancy test will be removed from the study.
  • Willingness to return have 8-10ml of blood drawn 25-30 days after the last Xenin infusion; to check for Xenin peptide antibodies that MAY develop. (All efforts will be made to complete this visit during study participation.)

Who cannot join

  • Lacks cognitive ability to sign the consent \&/or follow the study directions for themselves.
  • Women unwilling to comply with using an acceptable method of contraception during the course of the study, or who are currently breast-feeding.
  • Volunteers with a history of Acute Pancreatitis.
  • Volunteers with a history of cancer (except for skin cancer).
  • Volunteer with a history of Chronic Pancreatitis and/or risk factors for chronic pancreatitis including hypertriglyceridemia (triglycerides >400mg/ml) hypercalcemia (blood calcium level >11.md/dl) and/or the presence of gallstones.
  • Subjects taking medications known to affect glucose tolerance.
Show all 13Show fewer
  • Hematocrit from the lab is below 33% (or if the finger stick hemoglobin measured with the HemoCue 201+ is <11.2 g/dl).
  • Any major medical conditions, or conditions that in the opinion of the PI make the subject unsuitable for the study.
  • Subjects with abnormal kidney function as measured by the Creatinine concentration will be excluded.
  • Subjects with a history of active liver disease or AST/ALT levels >2X upper limit of normal will also be excluded.
  • Total Bilirubin levels should be <2.
  • Subjects unwilling to allow the use of their own blood or albumin in the preparation of the peptides. (The blood will prevent sticking of the peptide to the tubing; an alternative method has been sought but not found.)
  • Unwillingness to return have 8-10ml of blood drawn 25-30 days after the last Xenin infusion; to check for Xenin peptide antibodies that MAY develop. (All efforts will be made to complete this visit during study participation.)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

There is a marked and long-lasting improvement in glucose homeostasis that follows Roux-en-y gastric bypass surgery (RYGB) in humans. This improvement has been attributed in large part to an intestinal hormone, called GLP-1, that is released into the circulation immediately after eating. The purpose of this study is to determine if GLP-1 mediates the beneficial effects of RYGB surgery on glucose homeostasis in humans.

Read the detailed description

To conduct this study, we will enroll humans who previously underwent Roux-en-Y gastric bypass surgery, who are medically and weight stable and with no signs of type 2 diabetes either before or after surgery. Potential subjects will first be screened for eligibility and also to verify that they can safely participate in the study. Each study subject will be administered a meal tolerance test (MTT) on 3 separate occasions. For the MTT, a liquid meal (Boost Plus) will be ingested following an overnight fast. A primed-continuous infusion of vehicle alone (human albumin) or xenin-25 alone (at a dose of 4 or 12 pmoles x kg-1 x min-1) will be initiated 15 minutes before the meal is ingested. Blood samples will be collected before and during the MTT for the measurement of glucose and insulin levels, as well as a host of other hormones. A comparison of the results will tell us if the effects of xenin-25 on insulin release are mediated by GLP-1 in humans.

Being tested
Placebo, Lo-Xenin, Hi-Xenin, Extra Hi-Xenin
Keywords
Gastric Bypass, RYGB, GLP-1, Xenin, Insulin Secretion, Glucose Homeostasis, Vertical Sleeve, Lap Band

What participants receive

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

  • PlaceboDrug

    Also called Control, Albumin Alone

    A liquid mixed meal containing 1.5 grams of acetaminophen will be ingested in 7 equal portions from 0-30 minutes.

    Starting at minus 15 minutes, an intravenous infusion of albumin alone (placebo) will be administered for 5.25 hours.

  • Lo-XeninDrug

    Also called Lo-Xen

    A liquid mixed meal containing 1.5 grams of acetaminophen will be ingested in 7 equal portions from 0-30 minutes.

    Starting at minus 15 minutes, an intravenous infusion of xenin-25 at a dose of 4 pmoles/kg/min will be administered for 5.25 hours.

  • Hi-XeninDrug

    Also called Hi-Xen

    A liquid mixed meal containing 1.5 grams of acetaminophen will be ingested in 7 equal portions from 0-30 minutes.

    Starting at minus 15 minutes, an intravenous infusion of xenin-25 at a dose of 12 pmoles/kg/min will be administered for 5.25 hours.

  • Extra Hi-XeninDrug

    Also called XHi-Xen

    A liquid mixed meal containing 1.5 grams of acetaminophen will be ingested in 7 equal portions from 0-30 minutes.

    Starting at minus 15 minutes, an intravenous infusion of xenin-25 at a dose of 24 pmoles/kg/min will be administered for 5.25 hours.

Study groups in NCT02204813
Study groupRoleWhat they receive
Post RYGB SurgeryExperimentalHealthy, weight stable individuals, with previous Roux-en-Y gastric bypass surgery. No clinical evidence of type 2 diabetes before and after surgery. Each participant will receive placebo or the indicated doses of xenin-25.
Receives: Drug: Placebo; Drug: Lo-Xenin; Drug: Hi-Xenin; Drug: Extra Hi-Xenin

What is being measured

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

  1. Insulin secretion rates (ISRs) during each treatment

    ISRs will be measured at various times before and after ingestion of a liquid mixed meal.

    Measured: 5.5 hours

Secondary outcomes (5)

  1. Plasma glucose levels during each treatment.

    Plasma glucose levels will be measured at various times before and after ingestion of a liquid mixed meal.

    Measured: 5.5 hours

  2. Plasma glucagon levels during each treatment.

    Plasma glucagon levels will be measured at various times before and after ingestion of a liquid mixed meal.

    Measured: 5.5 hours

  3. Plasma GLP-1 during each treatment.

    Plasma GLP-1 levels will be measured at various times before and after ingestion of a liquid mixed meal.

    Measured: 5.5 hours

  4. Plasma C-peptide levels during each treatment.

    Plasma C-peptide levels will be measured at various times before and after ingestion of a liquid mixed meal.

    Measured: 5.5 hours

  5. The rate of gastric emptying during each treatment.

    The rate of gastric emptying will be estimated after ingestion of a liquid mixed meal.

    Measured: 5.5 hours

Timeline

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

  1. First posted30 Jul 2014 (estimated)
  2. Study startJul 2014
  3. Primary completion17 Nov 2015
  4. Study completion17 Nov 2015

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
Phase 1
Primary purpose
Basic science
Intervention model
Crossover
Model description
Patients with prior RYGB surgery receive all interventions, each on a separate day.
Masking
Single blind
Who is masked
Participant
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02204813
Sponsor's protocol ID
08-0861F
Other IDs
R01DK088126
Status last verified
Apr 2018
First submitted
28 Jul 2014
Last updated
27 Apr 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Sterl K, Wang S, Oestricker L, Wallendorf MJ, Patterson BW, Reeds DN, Wice BM. Metabolic responses to xenin-25 are altered in humans with Roux-en-Y gastric bypass surgery. Peptides. 2016 Aug;82:76-84. doi: 10.1016/j.peptides.2016.06.001. Epub 2016 Jun 7.

    PubMed 27288245

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lo-Xenin, Hi-Xenin and Extra Hi-Xenin in people with Bypass, Gastric and Roux-en-Y Gastric Bypass, run by Washington University School of Medicine 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 4 inclusion and 13 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 27 Apr 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Insulin secretion rates (ISRs) during each treatment (time frame: 5.5 hours). 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 NCT02204813, which also lists 1 linked publication.

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 27 Apr 2018.

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