HypoglycemiaPhase 1NCT02550145
Role of GLP-1 in Hyperinsulinemic Hypoglycemia Post-bariatric Surgery
A Phase 1 study testing Exendin (9-39) in people with Hypoglycemia, run by Tracey McLaughlin at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the role of GLP-1 in causing extreme postprandial glucose reductions after bariatric surgery in a subset of patients who have severe symptomatic hypoglycemia. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoglycemia
- What is being tested?
- Exendin (9-39)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Dec 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women ages 18-65
- BMI 25-40 with a clinical diagnosis of severe symptomatic hypoglycemia after bariatric surgery
Who cannot join
- Acute medical illness, such as acute bacterial or viral syndrome, febrile illness, acute abdominal symptoms, orthopedic injury within one week
- History of cardiac failure, renal insufficiency (estimated Crcl<30cc/min), hepatic insufficiency, chronic obstructive pulmonary disease, anemia (Hct<30%), or uncontrolled hypertension (SBP>160 or DBP>100)
- Pregnancy
- Use of medications that affect glucose metabolism
- Fasting glucose >150 or HbA1c>7.5 on Metformin
- Women of childbearing potential (will have a pregnancy test, in addition use of abstinence for at least one month prior to study or use two types of contraceptives, hormonal implant or Depo Provera)
- Active, uncontrolled psychiatric disease
- Participating in other studies or have received investigational medications within the past month or 5 half-lives of the drug, whichever is longer.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: The Role of GLP-1 in Mediating Glucose Reductions After Bariatric Surgery
The purpose of this study is to evaluate the role of GLP-1 in causing extreme postprandial glucose reductions after bariatric surgery in a subset of patients who have severe symptomatic hypoglycemia.
Read the detailed description
The physiologic mechanisms mediating the glucose-lowering effect of Roux-en-Y Gastric Bypass (RYGB) or post-Vertical Sleeve Gastrectomy (VSG) are unknown. The reduction in glucose excursions prior to weight loss has lead to postulates that the incretin hormone, GLP-1, may play an important role.
The purpose of this study is to evaluate the role of GLP-1 in causing extreme postprandial glucose reductions in a subset of post-bariatric patients through the pharmacologic blockade of the GLP-1 receptor in post-RYGB or post-VSG patients with severe symptomatic hypoglycemia.
- Conditions
- Hypoglycemia
- Being tested
- Exendin (9-39), Placebo
- Keywords
- Hyperinsulinemic, post-bariatric surgery
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exendin (9-39)Drug
IV infusion of Exendin (9-39) during standardized oral glucose tolerance test (OGTT).
PlaceboOther
IV infusion of Placebo (normal saline) during standardized oral glucose tolerance test (OGTT)
| Study group | Role | What they receive |
|---|---|---|
| Exendin(9-39) | Experimental | IV infusion of Exendin (9-39). Receives: Drug: Exendin (9-39) |
| Placebo | Placebo comparator | IV infusion of normal saline Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma glucose area under the curve
Measured: 0 to 180 minutes
Secondary outcomes (1)
Plasma insulin area under the curve
Measured: 0 to 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startFeb 2014
- Primary completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypoglycemiaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tracey McLaughlin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tracey McLaughlin, Stanford University
- Investigators
- Colleen Craig, M.D., Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02550145
- Sponsor's protocol ID
- 29010
- Status last verified
- Dec 2024
- First submitted
- 5 Jun 2015
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Craig CM, Liu LF, Deacon CF, Holst JJ, McLaughlin TL. Critical role for GLP-1 in symptomatic post-bariatric hypoglycaemia. Diabetologia. 2017 Mar;60(3):531-540. doi: 10.1007/s00125-016-4179-x. Epub 2016 Dec 14.
PubMed 27975209
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of GLP-1 in Mediating Glucose Reductions After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT02550145
- Acronym / sponsor ID
- 29010
- Conditions
- Hypoglycemia
- Keywords
- Hyperinsulinemic, post-bariatric surgery
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tracey McLaughlinUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- First posted
- 15 Sep 2015 (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.
The purpose of this study is to evaluate the role of GLP-1 in causing extreme postprandial glucose reductions after bariatric surgery in a subset of patients who have severe symptomatic hypoglycemia.
Detailed description
The physiologic mechanisms mediating the glucose-lowering effect of Roux-en-Y Gastric Bypass (RYGB) or post-Vertical Sleeve Gastrectomy (VSG) are unknown. The reduction in glucose excursions prior to weight loss has lead to postulates that the incretin hormone, GLP-1, may play an important role.
The purpose of this study is to evaluate the role of GLP-1 in causing extreme postprandial glucose reductions in a subset of post-bariatric patients through the pharmacologic blockade of the GLP-1 receptor in post-RYGB or post-VSG patients with severe symptomatic hypoglycemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exendin(9-39) | Experimental | Drug: Exendin (9-39)IV infusion of Exendin (9-39). |
| Placebo | Placebo comparator | Other: PlaceboIV infusion of normal saline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women ages 18-65
- BMI 25-40 with a clinical diagnosis of severe symptomatic hypoglycemia after bariatric surgery
Key exclusion criteria (8 listed)
- Acute medical illness, such as acute bacterial or viral syndrome, febrile illness, acute abdominal symptoms, orthopedic injury within one week
- History of cardiac failure, renal insufficiency (estimated Crcl<30cc/min), hepatic insufficiency, chronic obstructive pulmonary disease, anemia (Hct<30%), or uncontrolled hypertension (SBP>160 or DBP>100)
- Pregnancy
- Use of medications that affect glucose metabolism
- Fasting glucose >150 or HbA1c>7.5 on Metformin
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 |
|---|---|---|
| Exendin (9-39)IV infusion of Exendin (9-39) during standardized oral glucose tolerance test (OGTT). | Drug | Exendin(9-39) |
| PlaceboIV infusion of Placebo (normal saline) during standardized oral glucose tolerance test (OGTT) | Other | Placebo |
Primary outcome
Plasma glucose area under the curve
Time frame: 0 to 180 minutes
1 secondary outcome
Plasma insulin area under the curve
Time frame: 0 to 180 minutes
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Derived from this study: PubMed 27975209Craig CM, Liu LF, Deacon CF, Holst JJ, McLaughlin TL. Critical role for GLP-1 in symptomatic post-bariatric hypoglycaemia. Diabetologia. 2017 Mar;60(3):531-540. doi: 10.1007/s00125-016-4179-x. Epub 2016 Dec 14.
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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.
Colleen Craig, M.D. study director
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Exendin (9-39) in people with Hypoglycemia, run by Tracey McLaughlin 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 2 inclusion and 8 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: stopped early, as of the sponsor's last update on 4 Dec 2024. 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. Some participants in this study may receive a placebo. 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 was stopped early. Results are not available in the source record.
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?
Plasma glucose area under the curve (time frame: 0 to 180 minutes). 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 NCT02550145, 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 4 Dec 2024.