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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

Page last updated: August 23, 2015

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