Reactive Hypoglycemia
Conditions
Keywords
Reactive hypoglycemia, Sitagliptin, Glucagon-Like Peptide 1, Incretins, Prediabetes
Brief summary
The purpose of this study is to determine whether sitagliptin is effective in the treatment of reactive hypoglycemia by dysinsulinism.
Detailed description
Symptomatic reactive hypoglycemia is an abnormal glucose decrease after meal ingestion. Patients with this abnormality as an early manifestation of glucose intolerance are at higher risk of type 2 diabetes. The pathophysiology of this abnormality appears to be related with delayed first phase insulin release. Improvement of first phase insulin secretion and delay in gastric emptying induced by sitagliptin phosphate could have favorable effects in patients in whom delayed insulin secretion is associated with reactive hypoglycemia.
Interventions
DRUGPlacebo
Placebo 1 tablet per day per 2 weeks
DRUGSitagliptin phosphate
Sitagliptin phosphate 100 mg per day per 2 weeks
Sponsors
Merck Sharp & Dohme LLC
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Clinical and biochemical diagnosis of prediabetic reactive hypoglycemia * Must be able to swallow tablet * Negative pregnancy test (when appropriate)
Exclusion criteria
* Renal insufficiency * Hepatic insufficiency * Diabetes (any type)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical improvement assessed by a validated questionnaire | 2 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Glucose, insulin, GLP1, GIP | First and last evaluations |
Countries
Mexico
Outcome results
None listed