Trial · NCT02170870

Gastrointestinal Sensorimotor Dysfunctions in Diabetes Mellitus

NCT02170870, Phase 2, Completed, Mayo Clinic; results first posted 2019-04-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Gastrointestinal Sensorimotor Dysfunctions in Diabetes Mellitus. Trials, record NCT02170870. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02170870

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Gastrointestinal Sensorimotor Dysfunctions in Diabetes Mellitus
NCT number: NCT02170870
Status: Completed
Phases: Phase 2
Enrollment: 104 participants, actual
Lead sponsor: Mayo Clinic
Conditions: Dyspepsia, Diabetes Mellitus With Gastrointestinal Symptoms
Interventions: Exendin 9-39, Microlipid, Placebo
First posted: 2014-06-23
Last updated: 2019-04-23
Results first posted: 2019-04-23

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Mean Intestinal Chemosensitivity to Lipids Perfusion	Day 1, approximately 2 hours after infusion	Intestinal chemosensitivity was recorded by evaluating symptoms during duodenal lipid infusion (0.5 gm/mL diluted in water to 222 mL) and placebo or the glucagon like peptide 1 (GLP-1) receptor antagonist exendin 9-39 over 2 hours. Participants reported the severity of 6 symptoms (nausea, fullness, bloating, abdominal pain, belching, and burning) at 15 minute intervals using a Visual Analogue Scale (VAS) marked 0 (minimum value) - 4 (maximum value): absent (0), light (1), moderate (2), severe (3) and intolerable(4). The scores recorded for nausea, fullness, bloating, and abdominal pain over the 2 hour infusion were averaged and reported as the mean symptom score. Higher scores mean a worse outcome.
Secondary	Rate of Gastric Emptying (GE t 1/2) in Patients With Diabetes Mellitus (DM) or Non-ulcer Dyspepsia (NUD) Compared to Placebo	Day 1	The time for half of the ingested solids or liquids to leave the stomach. Following a meal consisting of two eggs labeled with technetium Tc 99m sulfur colloid (1 mCi) served on one slice of bread with milk labeled with indium In111 diethylenetriaminepentaacetate (0.1 mCi), gastric emptying of solids and liquids was assessed with scintigraphy. Rapid emptying is defined as ≥ 36% emptied at one hour and delayed emptying is defined as \< 76% emptied at four hours. Normal emptying is defined as amount less than rapid emptying definition but greater than delayed emptying definition.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Intestinal Chemosensitivity to Lipids Perfusion	Day 1, approximately 2 hours after infusion	Functional Dyspepsia arm - enteral lipid infusion was not performed because a nasoduodenal tube could not be placed in 2 functional dyspepsia placebo subjects and 3 functional dyspepsia exendin 9-39 subjects.	score on a scale	MEAN
SECONDARY	Rate of Gastric Emptying (GE t 1/2) in Patients With Diabetes Mellitus (DM) or Non-ulcer Dyspepsia (NUD) Compared to Placebo	Day 1		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group42

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Mean Intestinal Chemosensitivity to Lipids Perfusion	Healthy Controls Exendin 9-39		0.22	Standard Deviation 0.05	score on a scale
Mean Intestinal Chemosensitivity to Lipids Perfusion	Healthy Controls Placebo		0.36	Standard Deviation 0.13	score on a scale
Mean Intestinal Chemosensitivity to Lipids Perfusion	Diabetics Exendin 9-39		0.55	Standard Deviation 0.11	score on a scale
Mean Intestinal Chemosensitivity to Lipids Perfusion	Diabetics Placebo		0.65	Standard Deviation 0.17	score on a scale
Mean Intestinal Chemosensitivity to Lipids Perfusion	Functional Dyspepsia Exendin 9-39		1.4	Standard Deviation 0.9	score on a scale
Mean Intestinal Chemosensitivity to Lipids Perfusion	Functional Dyspepsia Placebo		1.2	Standard Deviation 0.9	score on a scale
Rate of Gastric Emptying (GE t 1/2) in Patients With Diabetes Mellitus (DM) or Non-ulcer Dyspepsia (NUD) Compared to Placebo	Healthy Controls	GE of solids / Rapid emptying	1		Participants
Rate of Gastric Emptying (GE t 1/2) in Patients With Diabetes Mellitus (DM) or Non-ulcer Dyspepsia (NUD) Compared to Placebo	Healthy Controls Placebo	GE of solids / Rapid emptying	3		Participants
Rate of Gastric Emptying (GE t 1/2) in Patients With Diabetes Mellitus (DM) or Non-ulcer Dyspepsia (NUD) Compared to Placebo	Diabetics Exendin 9-39	GE of solids / Rapid emptying	0		Participants
Rate of Gastric Emptying (GE t 1/2) in Patients With Diabetes Mellitus (DM) or Non-ulcer Dyspepsia (NUD) Compared to Placebo	Diabetics Placebo	GE of solids / Rapid emptying	5		Participants

1 to 10 of 42Source ClinicalTrials.gov

See all 42 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Healthy Controls Exendin 9-39	13
Overall Study	STARTED	Healthy Controls Placebo	11
Overall Study	STARTED	Diabetics Exendin 9-39	20
Overall Study	STARTED	Diabetics Placebo	20
Overall Study	STARTED	Functional Dyspepsia Exendin 9-39	20
Overall Study	STARTED	Functional Dyspepsia Placebo	20
Overall Study	COMPLETED	Healthy Controls Exendin 9-39	13
Overall Study	COMPLETED	Healthy Controls Placebo	11
Overall Study	COMPLETED	Diabetics Exendin 9-39	20
Overall Study	COMPLETED	Diabetics Placebo	20

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events36

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Hypotension	Cardiac disorders	Healthy Controls Exendin 9-39	0	13	0
other	Hypotension	Cardiac disorders	Healthy Controls Placebo	0	11	0
other	Hypotension	Cardiac disorders	Diabetics Exendin 9-39	1	20	1
other	Hypotension	Cardiac disorders	Diabetics Placebo	0	20	0
other	Hypotension	Cardiac disorders	Functional Dyspepsia Exendin 9-39	0	20	0
other	Hypotension	Cardiac disorders	Functional Dyspepsia Placebo	0	20	0
other	Severe fatigue	General disorders	Healthy Controls Exendin 9-39	0	13	0
other	Severe fatigue	General disorders	Healthy Controls Placebo	0	11	0
other	Severe fatigue	General disorders	Diabetics Exendin 9-39	0	20	0
other	Severe fatigue	General disorders	Diabetics Placebo	0	20	0

1 to 10 of 36Source ClinicalTrials.gov

See all 36 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Healthy Controls Exendin 9-39	0	13
Total, all-cause mortality	Healthy Controls Placebo	0	11
Total, all-cause mortality	Diabetics Exendin 9-39	0	20
Total, all-cause mortality	Diabetics Placebo	0	20
Total, all-cause mortality	Functional Dyspepsia Exendin 9-39	0	20
Total, all-cause mortality	Functional Dyspepsia Placebo	0	20
Total, other adverse events	Healthy Controls Exendin 9-39	0	13
Total, other adverse events	Healthy Controls Placebo	0	11
Total, other adverse events	Diabetics Exendin 9-39	2	20
Total, other adverse events	Diabetics Placebo	1	20

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
30358871	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
P01DK068055	Pathobiology of the Enteric System	FARRUGIA, GIANRICO; BHARUCHA, ADIL E.	MAYO CLINIC ROCHESTER	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2004 to 2019

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

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