Treatment With Sitagliptin for Reactive Hypoglycemia Secondary to Dysinsulinism
Information source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Reactive Hypoglycemia
Intervention: Sitagliptin phosphate (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Official(s) and/or principal investigator(s): Francisco J Gomez-Perez, MD, Principal Investigator, Affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Summary
The purpose of this study is to determine whether sitagliptin is effective in the treatment
of reactive hypoglycemia by dysinsulinism.
Clinical Details
Official title: Treatment With Sitagliptin Phosphate in Patients With Reactive Hypoglycemia Secondary to Dysinsulinism. A Controlled, Randomized, Double-blind, Clinical Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Clinical improvement assessed by a validated questionnaire
Secondary outcome: Glucose, insulin, GLP1, GIP
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico, DF 14000, Mexico
Additional Information
Click here for information of the study location Click here for information of study sponsor in spanish Click here for information of study sponsor in english
Starting date: December 2008
Last updated: April 22, 2011
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