Mystery of low blood sugar in Non-Diabetics under the microscope
NCT ID NCT04428723
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aims to understand why some people without diabetes experience low blood sugar (hypoglycemia). Researchers will compare three groups: people with hypoglycemia who have had stomach surgery, those with hypoglycemia who haven't had surgery, and healthy controls. They will analyze genetics, gut bacteria, and medical history to find possible causes.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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33 people
The number who actually took part.
- Started
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Aug 2020
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
3 groups: (1) patients with hypoglycemia, but without a history of bariatric or other gastrointestinal surgery, recruited from the Joslin Hypoglycemia Clinic, (2) patients with hypoglycemia and history of upper gastrointestinal surgery, recruited from the Joslin Hypoglycemia Clinic,(3) controls without hypoglycemia or surgery, recruited by local advertisement or from family members of patients with hypoglycemia. We plan to enroll patients with hypoglycemia continuously over the next 5 years.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. For hypoglycemia group without a history of bariatric surgery: Males or females diagnosed with hypoglycemia with prior episodes of neuroglycopenia. 2. For hypoglycemia group with history of upper gastrointestinal surgery: Males or females diagnosed with ongoing hypoglycemia with prior episodes of neuroglycopenia. 3. For non-surgical controls only: Males or females with no history of upper gastrointestinal surgery and no history of hypoglycemia or diabetes. 4. Age 18-70 years of age, inclusive, at screening. 5. 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: 1. Active treatment with any diabetes medications except for acarbose; 2. Known insulinoma, gastrinoma, or other neuroendocrine tumor; Additional exclusion criteria for those participating in optional Visit 2 (meal testing): 1. Chronic kidney disease stage 4 or 5 (including end-stage renal disease); 2. 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; 3. Congestive heart failure, New York Hear Association (NYHA) class II, III or IV; 4. 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; 5. History of syncope (unrelated to hypoglycemia) or diagnosed cardiac arrhythmia; 6. Concurrent administration of β-blocker therapy; 7. History of a cerebrovascular accident; 8. Seizure disorder (other than with suspect or documented hypoglycemia); 9. Active malignancy, except basal cell or squamous cell skin cancers; 10. Personal or family history of pheochromocytoma or disorder with increased risk of pheochromocytoma (MEN 2, neurofibromatosis, or Von Hippel-Lindau disease); 11. Major surgical operation within 30 days prior to screening; 12. Hematocrit \< 33% (women) or \<36% (men); 13. Bleeding disorder, treatment with warfarin, or platelet count \<50,000; 14. Blood donation (1 pint of whole blood) within the past 2 months; 15. Active alcohol abuse or substance abuse; 16. Current administration of oral or parenteral corticosteroids; 17. 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. 18. 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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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