Phase
Condition
Hormone Deficiencies
Diabetes (Pediatric)
Treatment
Mixed meal tolerance test
activity monitor
Continuous glucose monitoring
Clinical Study ID
Ages 18-70 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
For hypoglycemia group without a history of bariatric surgery: Males or femalesdiagnosed with hypoglycemia with prior episodes of neuroglycopenia.
For hypoglycemia group with history of upper gastrointestinal surgery: Males orfemales diagnosed with ongoing hypoglycemia with prior episodes of neuroglycopenia.
For non-surgical controls only: Males or females with no history of uppergastrointestinal 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 toattend a second visit with mixed meal test, and follow all study procedures
Exclusion
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 aspartateaminotransferase (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 serumbilirubin > 2.0;
Congestive heart failure, New York Hear Association (NYHA) class II, III or IV;
History of myocardial infarction, unstable angina or revascularization within thepast 6 months or 2 or more risk factors for coronary artery disease includingdiabetes, uncontrolled hypertension, uncontrolled hyperlipidemia, and active tobaccouse;
History of syncope (unrelated to hypoglycemia) or diagnosed cardiac arrhythmia;
Concurrent administration of β-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 ofpheochromocytoma (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 arequirement for a negative urine pregnancy test and for agreement to usecontraception during the study and for at least 1 month after participating in thestudy. Acceptable contraception includes birth control pill / patch / vaginal ring,Depo-Provera, Norplant, an intrauterine device (IUD), the double barrier method (thewoman 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.
Study Design
Study Description
Connect with a study center
Joslin Diabetes Center
Boston, Massachusetts 02215
United StatesSite Not Available

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