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TerminatedNCT02550145Updated Dec 4, 2024

Role of GLP-1 in Hyperinsulinemic Hypoglycemia Post-bariatric Surgery

A Phase 1 interventional study of Exendin (9-39) and Placebo in Hypoglycemia, sponsored by Tracey McLaughlin. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-04.

Sponsored by Tracey McLaughlin · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Feb 2014, registered Jun 2015).
Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Hypoglycemia

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Keywords

  • Hyperinsulinemic
  • post-bariatric surgery
03

In context

Hypoglycemia

654 studies on the registry are indexed under Hypoglycemia; 86 are open to participants now.

This study's enrollment of 10 is below the median of 29 across 479 interventional studies indexed under Hypoglycemia.

Browse Hypoglycemia studies →

Lead sponsor

Tracey McLaughlin is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Men and women ages 18-65
  • BMI 25-40 with a clinical diagnosis of severe symptomatic hypoglycemia after bariatric surgery

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Exendin(9-39)

    IV infusion of Exendin (9-39).

    Drug: Exendin (9-39)

  • Placebo comparator
    Placebo

    IV infusion of normal saline

    Other: Placebo

Interventions

  • DrugExendin (9-39)

    IV infusion of Exendin (9-39) during standardized oral glucose tolerance test (OGTT).

  • OtherPlacebo

    IV infusion of Placebo (normal saline) during standardized oral glucose tolerance test (OGTT)

06

What researchers measure

Primary outcomes

  1. Plasma glucose area under the curve

    Time frame: 0 to 180 minutes

Secondary outcomes

  1. Plasma insulin area under the curve

    Time frame: 0 to 180 minutes

Other outcomes

  1. Hypoglycemia symptom score

    Time frame: 0-180 minutes

07

Study locations

1 site
  • Stanford University School of Medicine
    Stanford, California 94305, United States
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2014 to primary completion in Dec 2016, 34 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 5, 2015
First posted
Sep 15, 2015
StartActual
Feb 2014
Primary completionActual
Dec 2016
Last update
Dec 4, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02550145
Lead sponsor
Tracey McLaughlin
Responsible party
Tracey McLaughlin (Associate Professor, Stanford University) — Sponsor-investigator
First posted
Sep 15, 2015
Start date
Feb 2014
Primary completion
Dec 2016
Last update
Dec 4, 2024

Study contacts

Colleen Craig, M.D.
study director · Stanford University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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