The Effectiveness of Lubiprostone in Constipated Diabetics
Condition: Constipation; Diabetes
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators will recruit a total of 136 diabetic men and women with constipation into
      this study from both The Emory Clinic and The Atlanta Veteran's Administration Hospital. The
      investigators will track spontaneous bowel movements defined as a bowel movement in 24 hours
      after initiation of study drug (SBMs) in all patients two weeks before treatment with
      lubiprostone as well as measure baseline colonic transit using the Smartpill pH capsule.
      Colon transit reflects that rate of colonic peristalsis and movement of stool through the
      large bowel.

      Patients will receive either lubiprostone 24 micrograms (mcg) orally twice a day for 8 weeks
      or placebo. Primary and secondary endpoints will be the number of SBMs/week and colonic
      transit time as measured by the Smartpill capsule, respectively. The number of SBMs/week will
      be evaluated at 0, 2, 4 and 8 weeks after initiation of therapy. The investigators will
      over-sample African American patients to achieve approximately 50% enrollment of this group.
      In a subanalysis, the investigators will assess response to treatment between the general
      population and African Americans.

      We hypothesize that lubiprostone will significantly increase the number of SBMs as well as
      decrease colonic transit time and improve quality of life in constipated diabetic patients
      compared with placebo.
    

Detailed description: 
      Diabetes mellitus (DM) is very common in the United States, and the incidence as well as
      prevalence of this disease are increasing. DM is not only a risk factor for cardiovascular
      and pulmonary conditions, but is also linked with several digestive complications. Among
      digestive complaints, constipation occurs in approximated two-thirds of patients with DM,
      making constipation the most common gastrointestinal (GI) complaint among type 2 diabetics.
      Consequently, these patients suffer abdominal pain, bloating, and have a lower health related
      quality of life when compared with patients without DM and GI symptoms.Constipated
      individuals may be reluctant to eat on a regular schedule which may worsen glycemic control
      as well as the symptoms related to an underlying diabetic enteropathy.

      Effective therapies for constipation are limited and there is little data evaluating the
      treatment of constipation, specifically in diabetic patients. Lubiprostone has been shown to
      be superior to placebo in increasing the number of spontaneous bowel movements (SBMs) in
      patients with chronic idiopathic constipation (CIC) and irritable bowel syndrome with
      constipation (IBS-C). However, lubiprostone has not been previously studied in diabetics
      suffering with constipation. Furthermore, other prokinetic pharmacotherapeutics targeted
      toward constipated patients with diabetes mellitus type 2 are lacking.

      African Americans have the highest rate of DM compared with other ethnic groups in the Unites
      States. Furthermore, constipation is more prevalent in African Americans compared with other
      minority groups. However, there is little data evaluating the prevalence of constipation and
      the response to treatment in African Americans. Therefore, more information regarding the
      severity of symptoms, differences in bowel patterns, colonic transit, and response to therapy
      is important to improving the management of constipation in this group. Hence, in a
      subanalysis, we will study whether the responsiveness of African American patients to
      lubiprostone differs from that of the general population.

      Given the dearth of information on the effectiveness of lubiprostone in diabetics, who have a
      particularly strong need for alternative safe and effective treatments for constipation, we
      propose to assess the effectiveness of lubiprostone in constipated diabetic men and women.

      This is a randomized double- blind placebo controlled trial of lubiprostone in the treatment
      of constipation in diabetic patients.
    

Intervention name(s): Lubiprostone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Lubiprostone will be given as 24 mcg orally twice a day.; A matched placebo pill will be given twice a day for 8 weeks.
Other intervention name(s): Amitiza
Intervention MeSH terms: Lubiprostone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Constipation; Diabetes; Lubiprostone; Amitiza; African Americans