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Efficacy of Lubiprostone Used With Polyethylene Glycol to Enhance Colonoscopy Preparation Quality in Diabetic Patients: A Randomized Single-Blind Controlled Trial

50 Years
Not Enrolling
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

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Trial Information

Efficacy of Lubiprostone Used With Polyethylene Glycol to Enhance Colonoscopy Preparation Quality in Diabetic Patients: A Randomized Single-Blind Controlled Trial


This is an investigator-initiated, single site (MCG only), single-blinded prospective study
comparing the efficacy of Lubiprostone and 4L PEG (Nulytely) to 4L PEG alone on preparation
quality in patients with known diabetes undergoing colonoscopy. Diabetic outpatients who
require a colonoscopy will be randomized to one of the two groups of 60 (total of 120

Control Group: All patients in the study will receive a standard oral 4L PEG colonoscopy
preparation the day prior to their scheduled colonoscopy.

Lubiprostone Group: The lubiprostone group will receive an additional two 24 mcg
lubiprostone capsules, which will be taken orally the morning and evening of the day of the
4L PEG prep (before and after the oral 4L PEG preparation).

Randomization Scheme: Subjects will be assigned to the Control Group or Lubiprostone Group,
on an odd/even basis. After research informed consent has been obtained, subjects are given
a study ID numbered 1 through 120. Subjects with an odd number will be assigned to Control
Group, and subjects with an even number will be assigned to the Lubiprostone Group.
Subjects then will be given a randomization package consisting of the preparation orders,
supplies, instructions and the date of their procedure by the investigator obtaining
informed consent. The colonoscopist will be blinded to which preparation was given.

Only diabetic patients who require an outpatient colonoscopy by a gastroenterologist at the
outpatient MCG Clinic will be eligible for the study. Patients will be presented with a
separate consent form for the colonoscopy procedure itself.

Standard of Care Procedures

- Colonoscopy Procedure Consent

- Colonoscopy

Study Procedures

- Research Informed Consent

- Disbursement of randomized preparation order and supplies, instructions, and date of
procedure to subjects

- Adverse Events

After the procedure, the physician who performed the colonoscopy will complete a form that
rates the quality of the subject's colonoscopy preparation on a 1-5 rating scale.

The subject's study participation duration is two days (day of preparation and day of
procedure). No follow-up visits will occur.

Inclusion Criteria:

- Patients with known diabetes (type I or II) undergoing elective colonoscopy at the
Medical College of Georgia.

- Patients aged 50 years and older.

- Women must be post-menopausal or surgically sterile.

- Patients able to give a valid, informed consent.

Exclusion Criteria:

- Patients with impaired glucose tolerance.

- Patients with suspected acute or chronic pseudo-obstruction.

- Patients with active gastrointestinal bleeding.

- Patients with known inflammatory bowel disease.

- Patients with chronic diarrhea.

- Patients with prior colonic resection.

- Patients with active diverticulitis.

- Patients with a known colonic mass.

- Patients with clinical evidence of decompensated liver disease.

- Patients with clinical evidence of decompensated renal disease or patients on

- Patients currently or previously taking lubiprostone.

- Patients with an allergy to lubiprostone.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Outcome Measure:

The primary measured endpoint will be the quality of colonoscopy preparations as rated by blinded colonoscopists by a 5-point Likert Scale, and compared using the chi-square statistics.

Outcome Time Frame:

End of study

Safety Issue:


Principal Investigator

Sherman M Chamberlain, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Georgia Regents University


United States: Food and Drug Administration

Study ID:

MCG 08-02-186



Start Date:

May 2008

Completion Date:

March 2010

Related Keywords:

  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
  • Colonoscopy
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
  • Cleansing
  • Preparation
  • PEG
  • Quality
  • Diabetes Mellitus
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2



Medical College of GeorgiaAugusta, Georgia  30912