Actively Recruiting

Phase 4
All Genders
Healthy Volunteers
NCT07351019

Colonoscopy Bowel Prep Comparison Among Diabetic Patients

Led by Eisenhower Army Medical Center · Updated on 2026-01-20

80

Participants Needed

1

Research Sites

27 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Colonoscopy Bowel Prep Comparison Among Diabetic Patients

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Provided informed consent with full understanding of study requirements and risks
  • Diagnosed with any type of diabetes mellitus as per current ACP guidelines
  • Aged 18 years or older
  • Undergoing average risk colorectal cancer screening, polyp surveillance, or have family history of cancer
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent due to mental condition
  • Have major systemic diseases (cardiovascular, hepatic, neurological, endocrine) that affect study participation or results
  • Have persistent significant or severe infection
  • Used any investigational drug in the last 6 months
  • Have liver function impairment with ALT, AST, or direct bilirubin levels over twice the normal limit
  • Are pregnant, breastfeeding, or plan to become pregnant during the study
  • Have significantly impaired bone marrow function or blood disorders such as anemia, leukopenia, or thrombocytopenia
  • History of colorectal cancer
  • Diagnosed with inflammatory bowel disease
  • Previous colon resection surgery
  • Prior colorectal surgery
  • Family history of hereditary polyposis or cancer syndromes including FAP, Gardner Syndrome, Turcot Syndrome, Lynch Syndrome, Cowden Syndrome, or Peutz-Jeghers Syndrome
  • Currently have symptoms like bleeding, diarrhea, constipation, or abdominal pain

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Trial Site Locations

Total: 1 location

1

Dwight D. Eisenhower Army Medical Center

Fort Gordon, Georgia, United States, 30905

Actively Recruiting

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Research Team

D

Darrell F Barker MD, FACG, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SCREENING

Number of Arms

2

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