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Gastrointestinal Sensorimotor Dysfunctions in Diabetes Mellitus

NCT02170870 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2019-04-23

Study results available
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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.

Conditions

  • Dyspepsia
  • Diabetes Mellitus With Gastrointestinal Symptoms

Interventions

DRUG

Exendin 9-39

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

DRUG

Microlipid

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

DRUG

Placebo

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

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Adil Bharucha, MBBS, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2017-11-17
Completion
2017-11-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02170870 on ClinicalTrials.gov