Post-Prandial Carbohydrate Metabolism in Individuals With and Without Post-Bariatric Surgery Hypoglycemia (PBH)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Joslin Diabetes Center
Study ID
NCT07818707
Phase
PHASE4
Status
Recruiting
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Conditions

  • Bariatric Surgery
  • Hypoglycemia
  • Hypoglycemia, Reactive

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Glucagon for Injection (Fresenius Kabi USA) — DRUG
    The investigators are assessing glucagon metabolism in individuals with and without PBH in fasting and post-prandial states.
  • [6,6-2H2] glucose — DRUG
    The investigators are using a stable isotope glucose tracer to assess glucose metabolism in individuals with and without PBH in fasting and post-prandial states.
  • [13C9, 15N1]-glucagon — DRUG
    The investigators are assessing the metabolism of glucagon in individuals with and without PBH in fasting and post-prandial states.
  • [1-13C] glucose — DRUG
    The investigators are assessing the metabolism of glucose in individuals with and without PBH in fasting and post-prandial states.
  • [2-13C] glucose — DRUG
    The investigators assessing the metabolism of glucose in individuals with and without PBH in fasting and post-prandial states.

Study Details

In this study, the investigators will determine (a) whether metabolism (secretion and turnover) of glucagon is altered in patients with PBH, (b) whether this is affected by a meal, (c) whether PBH affects the ability of the body to produce glucose (endogenous glucose production), and (d) whether PBH affects the amount of glycogen in the liver (storage form of glucose) when fasting and after a meal. The investigators will determine the effect of glucagon to raise glucose levels after a meal. To answer these questions, participants will receive an infusion of a stable (nonradioactive) isotope of glucose and glucagon, and a meal containing a stable isotope of glucose. Glycogen will be measured by magnetic resonance imaging (MRI) of the liver before and after the meal. This information will be used to develop computer models for the glucagon pump system.

Key Dates

First listed
Sep 14, 2026
Start date
Jan 27, 2026
Status verified
Sep 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: RYGB non-hypoglycemia
    Individuals that underwent Roux-en-y gastric bypass (RYGB) at least 2 years prior to recruitment and do not have a diagnosis of PBH.
  • Experimental: Post-Bariatric Hypoglycemia (PBH)
    Individuals that underwent RYGB at least 2 years prior to recruitment and have a diagnosis of PBH.

Primary Outcome Measure

Between-group differences in iAUC for postprandial EGP [ Time Frame: During Visit 2, within 10 days of the baseline visit ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of AlabamaBirminghamAlabama35294
Ananda Basu, MD
[email protected]
205-975-0471
Joslin Diabetes CenterBostonMassachusetts02215
Mary-Elizabeth Patti, MD
[email protected]
617-309-2400

Find similar trials in Birmingham, AL

By research site
University of Alabama· Birmingham, ALJoslin Diabetes Center· Boston, MA

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