Colonoscopy Bowel Prep Comparison Among Diabetic Patients

Colonoscopy Bowel Prep Comparison Among Diabetic Patients: Golytely v. SUPREP

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:

1. Is there a significant difference in bowel prep cleanse between Golytely and SUPREP in patients with diabetes based on the Boston Bowel Prep Score (BBPS) as assessed by blinded, skilled endoscopists?
2. Is there a significant difference in patients' tolerance between the bowel preparations as assessed by the validated Mayo Bowel Prep Tolerability Form (MBPTF)?

Participants will:

• 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.

Study Overview

• Status: Recruiting
• Conditions: Colon Cancer Screening
• Intervention / Treatment: Drug: Golytely; Drug: SUPRPEP

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Darrell F Barker MD, FACG, MD; Phone Number: 706-836-9829; Email: darrell.f.barker.mil@health.mil

Study Locations

• United States
  • Georgia
    • Fort Gordon, Georgia, United States, 30905
      • Recruiting
      • Dwight D. Eisenhower Army Medical Center
      • Contact: Darrell F Barker MD, FACG, MD; Phone Number: 706-836-9829; Email: darrell.f.barker.mil@health.mil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 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.
2. Diabetic volunteer (defined per current ACP guidelines, and any type of DM)
3. Aged 18+ years, inclusive
4. Average screening risk, polyp surveillance, and family history of cancer

Exclusion Criteria:

1. 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
2. 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
3. Persistent significant or severe infection, either acute or chronic
4. Prior use of any investigational drug in the preceding 6 months
5. 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).
6. Pregnant or breast-feeding women or those who plan to become pregnant during the study

7. Participants with significantly impaired bone marrow function or significant anemia, leukopenia, or thrombocytopenia (confirmed by retest):

   1. Hematocrit < 35% and/or
   2. Absolute white blood cell count < 3000 cells/mm3 ( L) and/or
   3. Platelet count < 150 000 cells/mm3 ( L) and/or- Absolute neutrophil = 1500 cells/mm3 ( L)
8. History of colorectal cancer
9. Inflammatory Bowel Disease
10. Past surgical history of colon resection
11. Prior history of colorectal surgery
12. 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
13. Symptomatic patients (bleeding, diarrhea, constipation, abdominal pain)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Diabetic patients undergoing bowel prep for screening colonoscopy using Golytely	Drug: Golytely; Bowel cleanliness and patient tolerability
Active Comparator: Diabetic patients undergoing bowel prep for screening colonoscopy using SUPREP	Drug: SUPRPEP; Bowel cleanliness and patient tolerability

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Eisenhower Army Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): January 16, 2026
• Primary Completion (Estimated): July 28, 2026
• Study Completion (Estimated): July 28, 2026

Study Registration Dates

• First Submitted: January 15, 2026
• First Submitted That Met QC Criteria: January 16, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Golytely
• Other Study ID Numbers: DDEAMC.2022.0044

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No