NCT07818707 Post-Prandial Carbohydrate Metabolism in Individuals With and Without Post-Bariatric Surgery Hypoglycemia (PBH)
| NCT ID | NCT07818707 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Joslin Diabetes Center |
| Condition | Hypoglycemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-01-27 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2026-01-27 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Age 18-70 years of age, inclusive, at screening. * Willingness to provide informed consent and follow all study procedures, including attending all scheduled visits. * Males or females at least 2 years following Roux-en-Y gastric bypass (RYGB) * For patients recruited to PBH group: diagnosed with ongoing PBH, with documented episodes of hypoglycemia, and history of fulfillment of Whipple's triad. Exclusion Criteria: * Documented hypoglycemia occurring only in the fasting state (\>12 hours fast); * Current diabetes, defined as hemoglobin A1c \>6.5% or use of diabetes medications, except for acarbose or miglitol; * Chronic kidney disease stage 4 or 5 (including end-stage renal disease); * Hepatic disease, including serum ALT or AST greater than 2 times the upper limit of normal; hepatic synthetic insufficiency as defined as serum albumin \< 3.0 g/dL; or serum bilirubin \> 2.0; * Congestive heart failure, NYHA class II, III or IV; * History of myocardial infarction, unstable angina or revascularization within the past 6 months. * Two or more risk factors for coronary artery disease including diabetes, uncontrolled hypertension, uncontrolled hyperlipidemia, and active tobacco use. * History of recurrent syncope (unrelated to hypoglycemia) or active diagnosis of a cardiac arrhythmia; * Current administration of β-blocker therapy; * History of a cerebrovascular accident; * Seizure disorder (other than with suspect or documented hypoglycemia); * Active treatment with long-acting (LAR) octreotide or pasireotide; * Active malignancy, except basal cell or squamous cell skin cancers; * Personal or family history of pheochromocytoma or disorder with increased risk of pheochromocytoma (MEN 2, neurofibromatosis, or Von Hippel-Lindau disease); * Known insulinoma; * Major surgical operation within 30 days prior to screening; * Clinically significant anemia as defined as a hematocrit \< 33%; * Bleeding disorder, treatment with warfarin, or platelet count \<50,000; * Blood donation (1 pint of whole blood) within the past 2 months; * Active alcohol abuse or substance abuse; * Current administration of oral or parenteral corticosteroids; * Pregnancy and/ or lactation: For persons of childbearing potential: there is a requirement for a negative urine pregnancy test before any procedures. * Not enrolled in another study that uses an investigational drug for this condition.
Contact & Investigator
Ananda Basu, MD
PRINCIPAL INVESTIGATOR
University of Alabama at Birmingham
Frequently Asked Questions
Who can join the NCT07818707 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Hypoglycemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07818707 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07818707 currently recruiting?
Yes, NCT07818707 is actively recruiting participants. Visit ClinicalTrials.gov or contact Joslin Diabetes Center to inquire about joining.
Where is the NCT07818707 trial being conducted?
This trial is being conducted at Birmingham, United States, Boston, United States.
Who is sponsoring the NCT07818707 clinical trial?
NCT07818707 is sponsored by Joslin Diabetes Center. The principal investigator is Ananda Basu, MD at University of Alabama at Birmingham. The trial plans to enroll 40 participants.