Golytely versus SUPREP bowel preparation for colonoscopy in adults with diabetes

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

This compares Golytely and SUPREP to see if one cleans better and is easier to tolerate for adults with diabetes preparing for a colonoscopy.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sex: All
• Sponsor: Eisenhower Army Medical Center (Federal)
• Locations: 1 site (Fort Gordon, Georgia)
• Trial ID: NCT07351019 on ClinicalTrials.gov

What this trial studies

Adults with diabetes who are having screening, surveillance, or colonoscopy for family history are randomized to receive either Golytely (PEG) or SUPREP (sodium sulfate) bowel preparation. Participants complete a validated tolerability questionnaire (Mayo Bowel Prep Tolerability Form) on the day of the procedure. A blinded, skilled endoscopist documents bowel cleanliness using the Boston Bowel Preparation Scale (BBPS) during a standardized colonoscopy. The primary outcomes are BBPS scores comparing cleansing quality and patient-reported tolerability between the two preparations at a single center.

Who should consider this trial

Good fit: Adults aged 18 and older with diabetes who are average-risk for colorectal cancer, undergoing screening, polyp surveillance, or with relevant family history and who can give informed consent are eligible.

Not a fit: People with major uncontrolled systemic disease, persistent severe infection, inability to consent, or other exclusionary medical conditions (and non-diabetics) are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, the trial could identify the bowel prep that gives cleaner colons and is easier for patients with diabetes to tolerate, potentially improving polyp detection and reducing repeat procedures.

How similar studies have performed: Previous head-to-head comparisons in general populations have shown SUPREP often matches or is better tolerated than PEG-based preps, but direct evidence focused specifically on people with diabetes is limited.

Eligibility criteria

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)

Where this trial is running

Fort Gordon, Georgia

• Dwight D. Eisenhower Army Medical Center — Fort Gordon, Georgia, United States (Recruiting)

Study contacts

• Study coordinator: Darrell F Barker MD, FACG, MD

Conditions Colon Cancer Screening