CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 104 enrolled
Drug / intervention
Exendin 9-39 +2 moredrug
Likely dose
Microlipid 66.7 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02170870
NCT02170870Phase 2Completed
CompareCT.gov

Gastrointestinal Sensorimotor Dysfunctions in Diabetes Mellitus

Mayo Clinic·interventional·Posted Jun 23, 2014·Updated Apr 23, 2019

In Brief

A Phase 2 clinical trial evaluating Exendin 9-39, Microlipid, and 1 other intervention for Dyspepsia and Diabetes Mellitus With Gastrointestinal Symptoms. Completed, enrolled 104 participants across 1 site.

Detailed Summary

The purpose of this study is to understand why people with indigestion have gastrointestinal symptoms and in particular to understand whether symptoms are related to increased sensitivity to nutrients in the small intestine and to a hormone (GLP1) which is normally released from the small intestine in response to nutrients. We propose to study the contribution of GLP1 to intestinal sensitivity with a drug (exendin 9-39) that blocks the effects of GLP1.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDyspepsia, Diabetes Mellitus With Gastrointestinal Symptoms
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 23, 2014
Enrollment StartJun 1, 2014
Primary CompletionNov 17, 2017
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 12.0 years ago

Interventions

Exendin 9-39drug

Exendin 9-39 will be administered intravenously (1,200 pmol/kg bolus followed by infusion at 300 pmol/kg/min).

Microlipiddrug

Lipid infusion {66.7 mL Microlipid (0.5 gm/mL diluted in water to 222 ml).

Placebodrug

Normal saline infusion will be prepared to match the appearance of Exendin 9-39