Clinical Trial Details
| Trial ID: | L4150 |
| Source ID: | NCT01252524 |
| Associated Drug: | Placebo |
| Title: | Effect of Calcium Polycarbophil on Type II Diabetes Mellitus Control: a Randomized Double-blind Study |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus Type II |
| Interventions: | DRUG: Placebo|DRUG: Calcium polycarbophil |
| Outcome Measures: | Primary: Change in Hemoglobin A1c from baseline, Change in hemoglobin A1c will be measured during these time intervals to determine the effects of polycarbophil on diabetes mellitus control., Enrollment, 3 months, 6 months | Secondary: Weight, Baseline, 3 months, 6 months|Blood Pressure, Baseline, 3 months, 6 months|Number and dosage of medications for DM, HTN, and hyperlipidemia, Baseline, 3 months, 6 months|Serum LDL, HDL, triglycerides, total cholesterol, Baseline, 3 months, 6 months|Adverse outcomes, GI discomfort, constipation, excessive flatulence, fecal impaction, diarrhea, nausea, vomiting, hypoglycemia, other reported side effects., 3 months, 6 months |
| Sponsor/Collaborators: | Sponsor: East Carolina University |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | |
| Enrollment: | 48 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2010-10 |
| Completion Date: | 2011-04 |
| Results First Posted: | |
| Last Update Posted: | 2012-09-03 |
| Locations: | East Carolina University Family Medicine Center, Greenville, North Carolina, 27834, United States |
| URL: | https://clinicaltrials.gov/show/NCT01252524 |
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