Colonoscopy Bowel Prep Comparison Among Diabetic Patients

Eisenhower Army Medical Center

Status and phase

Enrolling

Phase 4

Conditions

Colon Cancer Screening

Treatments

Drug: Golytely

Drug: SUPRPEP

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT07351019

DDEAMC.2022.0044

Details and patient eligibility

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:

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?
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.

Enrollment

80 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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):
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)
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
Symptomatic patients (bleeding, diarrhea, constipation, abdominal pain)