Colonoscopy Bowel Prep Comparison Among Diabetic Patients

NCT07351019 | Recruiting Phase 4 FDA Drug

• 1 other identifier: DDEAMC.2022.0044
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if the Golytely or SUPREP bowel preparation works more effectively in bowel cleansing for colorectal cancer screening with colonoscopy in patients with diabetes. The main questions this study aims to answer are:

• Be randomized to take either Golytely or SUPREP bowel preparation prior to their colonoscopy
• Complete the MBPTF on the procedure date prior to the scheduled colonoscopy
• Undergo a standardized screening colonoscopy during which time a blinded endoscopist will document the participant's BBPS The research team hypothesizes that SUPREP will have a significant difference in tolerability (based on MBPTF), while exhibiting no difference in bowel cleanse (based on BBPS) in the diabetic patient population.

Conditions

Colon Cancer Screening

Outcome Measures

Primary Outcomes (2)

• Bowel cleanliness using the Boston Bowel Prep Score (BBPS)

  The BBPS uses a score from 0-9 which helps quantify bowel cleanliness after bowel prep prior to colonoscopy. A higher score indicates better visualization of the colon mucosa. This will be assessed by blinded, skilled endoscopists.

  Procedural (during the participant's screening colonoscopy)

• Use of the Mayo Bowel Prep Tolerability Score (MTS)

  The questionnaire is a validated scoring system used to assess the tolerability (ex. symptoms) and experience (ex. likelihood of using the bowel prep again) among diabetic patients undergoing the study.

  Pre-procedural (prior to the participant's screening colonoscopy)

Study Arms (2)

Diabetic patients undergoing bowel prep for screening colonoscopy using Golytely

ACTIVE COMPARATOR

Drug: Golytely

Diabetic patients undergoing bowel prep for screening colonoscopy using SUPREP

ACTIVE COMPARATOR

Drug: SUPRPEP

Interventions

Golytely DRUG

Bowel cleanliness and patient tolerability

Diabetic patients undergoing bowel prep for screening colonoscopy using Golytely

SUPRPEP DRUG

Bowel cleanliness and patient tolerability

Diabetic patients undergoing bowel prep for screening colonoscopy using SUPREP

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants having provided informed consent with signature on informed consent form: the informed consent process should be complete with full discussion of all requirements and possible risks.
• Diabetic volunteer (defined per current ACP guidelines, and any type of DM)
• Aged 18+ years, inclusive
• Average screening risk, polyp surveillance, and family history of cancer

You may not qualify if:

• Unable to provide informed consent to participate in the study Such as a mental condition rendering the participant unable to understand the nature, scope, and possible consequences of the study
• Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult or that would put the participant at risk by participating in the study
• Persistent significant or severe infection, either acute or chronic
• Prior use of any investigational drug in the preceding 6 months
• Liver function impairment or persisting elevations (confirmed by retest) of alanine aminotransferase (ALT), aspartate aminotransferase (AST), or direct bilirubin greater than 2x the upper limit of normal range (ULN).
• Pregnant or breast-feeding women or those who plan to become pregnant during the study
• Participants with significantly impaired bone marrow function or significant anemia, leukopenia, or thrombocytopenia (confirmed by retest):
• Hematocrit \< 35% and/or
• Absolute white blood cell count \< 3000 cells/mm3 ( L) and/or
• Platelet count \< 150 000 cells/mm3 ( L) and/or- Absolute neutrophil = 1500 cells/mm3 ( L)
• History of colorectal cancer
• Inflammatory Bowel Disease
• Past surgical history of colon resection
• Prior history of colorectal surgery
• Family history of hereditary polyposis and cancer disorders to include but not limited to FAP (Familial Adenomatous Polyposis), Gardner Syndrome, Turcot Syndrome, Lynch Syndrome, Cowden Syndrome, and Peutz-Jeghers Syndrome

Sponsors & Collaborators

• Eisenhower Army Medical Center: lead

Study Sites (1)

Dwight D. Eisenhower Army Medical Center

Fort Gordon, Georgia, 30905, United States

RECRUITING

MeSH Terms

Interventions

Golytely

Central Study Contacts

Darrell F Barker MD, FACG, MD

CONTACT

706-836-9829; darrell.f.barker.mil@health.mil

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: January 20, 2026
• Study Start: January 16, 2026
• Primary Completion (Estimated): July 28, 2026
• Study Completion (Estimated): July 28, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

US (1)