Mechanisms of Hypoglycemia in Patients Without Diabetes

STATUS

Recruiting
End date

May 5, 2025
participants needed

100
sponsor

Joslin Diabetes Center

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Updated on 19 February 2024

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diabetes

hypoglycemia

continuous glucose monitoring

gastrointestinal surgery

bariatric surgery

genetic variation

tolerance test

neuroglycopenia

Summary

The goal of this study is to identify physiologic and molecular mechanisms that underlie hypoglycemia in the absence of diabetes (or medications that can cause hypoglycemia) and to investigate potential genetic and microbiome differences which contribute to hypoglycemia. We will test the hypothesis that hypoglycemia in the absence of diabetes is linked to genetic variation or the microbiome, and identify whether additional medical history or diagnoses are enriched in the population of patients with hypoglycemia.

Description

Although there are several conditions which have been identified that cause, or contribute to hypoglycemia, diagnosis can be challenging, as the physiologic, and molecular mechanisms are incompletely understood. Additionally, treatment options are relatively limited, and often incompletely effective and/or not well tolerated. Investigating the causative factors and mechanisms of hypoglycemia is important therefore in improving our understanding in order to develop new and more effective approaches to treatment.

The current study aims to:

more fully characterize clinical history and demographics in patients with diverse forms of hypoglycemia by creating and analyzing a patient database;
for a subset of patients, characterize metabolic and hormonal responses to a standard meal;
analyze DNA variants in individuals with hypoglycemia;
analyze differences in the intestinal microbiome in individuals with hypoglycemia.

Details

Condition	Hypoglycemia, Hypocalcemia
Age	18-70 years
Treatment	Activity Monitor, Continuous Glucose Monitoring, Entry of demographic and medical history data into a deidentified database, Blood sample for DNA analysis, Stool sample for microbiome analysis, Mixed meal tolerance test
Clinical Study Identifier	NCT04428723
Sponsor	Joslin Diabetes Center
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	For hypoglycemia group without a history of bariatric surgery: Males or females diagnosed with hypoglycemia with prior episodes of neuroglycopenia
	For hypoglycemia group with history of upper gastrointestinal surgery: Males or females diagnosed with ongoing hypoglycemia with prior episodes of neuroglycopenia
	For non-surgical controls only: Males or females with no history of upper gastrointestinal surgery and no history of hypoglycemia or diabetes
	Age 18-70 years of age, inclusive, at screening
	Willingness to provide informed consent and attend one study visit, with option to attend a second visit with mixed meal test, and follow all study procedures
Exclusion Criteria
	Active treatment with any diabetes medications except for acarbose
	Known insulinoma, gastrinoma, or other neuroendocrine tumor
	Additional exclusion criteria for those participating in optional Visit 2
	(meal testing)
	Chronic kidney disease stage 4 or 5 (including end-stage renal disease)
	Hepatic disease, including serum alanine transaminase (ALT) or aspartate aminotransferase (AST) greater than or equal to 3 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, New York Hear Association (NYHA) class II, III or IV
	History of myocardial infarction, unstable angina or revascularization within the past 6 months or 2 or more risk factors for coronary artery disease including diabetes, uncontrolled hypertension, uncontrolled hyperlipidemia, and active tobacco use
	History of syncope (unrelated to hypoglycemia) or diagnosed cardiac arrhythmia
	Concurrent administration of -blocker therapy
	History of a cerebrovascular accident
	Seizure disorder (other than with suspect or documented hypoglycemia)
	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)
	Major surgical operation within 30 days prior to screening
	Hematocrit < 33% (women) or <36% (men)
	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 women of childbearing potential: there is a requirement for a negative urine pregnancy test and for agreement to use contraception during the study and for at least 1 month after participating in the study. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an intrauterine device (IUD), the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence
	Use of an investigational drug within 30 days prior to screening
	There will be no involvement of special vulnerable populations such as
	fetuses, neonates, pregnant women, children, prisoners, institutionalized or
	incarcerated individuals, or others who may be considered vulnerable
	populations

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Mechanisms of Hypoglycemia in Patients Without Diabetes