Phase
Condition
Hormone Deficiencies
Diabetes (Pediatric)
Treatment
Dexcom continuous glucose monitor and activity monitor
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria
Males or females diagnosed with ongoing post-bariatric, post-gastric surgery or other forms of postprandial hypoglycemia with prior episodes of neuroglycopenia
Age 18-65 years of age, inclusive, at screening.
Willingness to provide informed consent and follow all study procedures, including attending all scheduled visits.
Exclusion Criteria
Documented hypoglycemia occurring in the fasting state (> 12 hours fast);
Chronic kidney disease stage 4 or 5 (including end-stage renal disease);
Hepatic disease, including serum alanine aminotransferase (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 Heart 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 β-blocker therapy;
History of a cerebrovascular accident;
Seizure disorder (other than with suspect or documented hypoglycemia);
Active treatment with any diabetes medications except for acarbose;
Active treatment with octreotide or diazoxide;
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;
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 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.
Study Design
Study Description
Connect with a study center
Joslin Diabetes Center
Boston, Massachusetts 02215
United StatesActive - Recruiting
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