NCT02078726

Brief Summary

The investigators believe that glucagon therapy will have a positive impact on key parameters of colonoscopy such as cecal intubation time, withdrawal time, total procedure time, adenoma detection rate, endoscopist's assessment of the difficulty of the procedure, patient comfort, and patient's willingness to undergo a repeat colonoscopy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 5, 2014

Completed
27 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
3 years until next milestone

Results Posted

Study results publicly available

April 20, 2021

Completed
Last Updated

July 3, 2025

Status Verified

July 1, 2025

Enrollment Period

4.1 years

First QC Date

February 24, 2014

Results QC Date

March 24, 2021

Last Update Submit

July 1, 2025

Conditions

Keywords

glucagon, screening colonoscopy

Outcome Measures

Primary Outcomes (1)

  • Adenoma Detection Rate (ADR) During Colonoscopy Procedure

    ADR was defined as the percentage of participants with at least one traditional adenoma (including tubular or villous adenomas, and adenomas with high grade dysplasia or adenocarcinoma) of any size.

    During colonoscopy procedure (an average of 1139 seconds for Glucagon Arm and 1353 seconds for Placebo Arm)

Study Arms (2)

Glucagon

ACTIVE COMPARATOR

1 mg glucagon given during colonoscopy through an IV

Drug: Glucagon

Placebo

PLACEBO COMPARATOR

1 mL normal saline given during colonoscopy through an IV

Drug: Glucagon

Interventions

glucagon (hormone produced by the body) administered through IV

GlucagonPlacebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any subject who has already been already cleared for and scheduled to undergo colonoscopy at SFGH endoscopy center.

You may not qualify if:

  • Refusal to give informed consent.
  • Age \<18 or \>70.
  • Prior intra-abdominal surgery
  • Diabetes
  • Pheochromocytoma
  • Insulinoma
  • Liver disease (Child-Pugh Score \>6)
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco General Hospital

San Francisco, California, 94117, United States

Location

Related Publications (1)

  • Anupam Aditi, Trilokesh Dey Kidambi, Angel Espinoza, Nicholas Crowley, Alex Rodas, John Patrick Cello. Glucagon Shortens Cecal Intubation Time and Total Procedure Time During Colonoscopy: A Prospective, Double-Blind Placebo Controlled Randomized Trial. Biomedical Journal of Scientific & Technical Research. 2019; 22(2).

    RESULT

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Glucagon

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

ProglucagonPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
John Cello, MD
Organization
University of California, San Francisco

Study Officials

  • John Cello, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2014

First Posted

March 5, 2014

Study Start

April 1, 2014

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

July 3, 2025

Results First Posted

April 20, 2021

Record last verified: 2025-07

Locations