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Effect of Calcium Polycarbophil on Type II Diabetes Mellitus Control: a Randomized Double-blind Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tae Joon Lee, East Carolina University
ClinicalTrials.gov Identifier:
NCT01252524
First received: November 5, 2010
Last updated: August 31, 2012
Last verified: August 2012
History of Changes
  Purpose

The purpose of this study is to determine whether a form of fiber if effective in improving the treatment of type 2 diabetes. Measurements of other possible medical benefits will include blood pressure, cholesterol, weight, and the number/dosage of medications used for diabetes, hypertension, and high cholesterol.


Condition Intervention
Diabetes Mellitus Type II
 Drug: Placebo
Drug: Calcium polycarbophil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Calcium Polycarbophil on Type II Diabetes Mellitus Control: a Randomized Double-blind Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by East Carolina University:

Primary Outcome Measures:
  • Change in Hemoglobin A1c from baseline [ Time Frame: Enrollment, 3 months, 6 months ] [ Designated as safety issue: No ]
    Change in hemoglobin A1c will be measured during these time intervals to determine the effects of polycarbophil on diabetes mellitus control.


Secondary Outcome Measures:
  • Weight [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
  • Blood Pressure [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
  • Number and dosage of medications for DM, HTN, and hyperlipidemia [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
  • Serum LDL, HDL, triglycerides, total cholesterol [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
  • Adverse outcomes [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: Yes ]
    GI discomfort, constipation, excessive flatulence, fecal impaction, diarrhea, nausea, vomiting, hypoglycemia, other reported side effects.


Enrollment: 48
Study Start Date: October 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
A placebo tablet PO TID before each meal with 8 oz of water for 6 months.
 Drug: Placebo
Placebo tablet po TID before each meal with 8 oz of water for 6 months
Experimental: Calcium polycarbophil
Calcium polycarbophil 625 mg PO TID before each meal with 8 oz of water for 6 months
 Drug: Calcium polycarbophil
calcium polycarbophil 625 mg po TID before each meal with 8 oz water for 6 months
Other Names:
  • Konsyl
  • Fibercon

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 and older
  • Diagnosed with type II diabetes mellitus for at least 24 months
  • At least 4 office visits within the past 24 months for diabetes mellitus follow up at ECU Family Medicine Center
  • Hemoglobin A1c within the past six months between 8% to 10%

Exclusion Criteria:

  • Dementia diagnosis or other psychiatric diagnoses that preclude the patient from being able to consent for this study by him/herself
  • Already taking fiber supplementation (polycarbophil, psyllium, methylcellulose)
  • Severe problems with previous use of fiber supplementation
  • Dysphagia or other swallowing disorders, preventing the subject from swallowing pills or 8 oz of water
  • Pregnancy during the study period
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01252524

Locations
United States, North Carolina
East Carolina University Family Medicine Center
Greenville, North Carolina, United States, 27834
Sponsors and Collaborators
East Carolina University
Investigators
Principal Investigator: Tae J Lee, MD, CMD East Carolina University
  More Information

Publications:

Responsible Party: Tae Joon Lee, Clinical Associate Professor, East Carolina University
ClinicalTrials.gov Identifier: NCT01252524     History of Changes
Other Study ID Numbers: 10-0422
Study First Received: November 5, 2010
Last Updated: August 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by East Carolina University:
diabetes mellitus
fiber
glycemic control
calcium polycarbophil

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Calcium, Dietary
Calcium polycarbophil
Psyllium
 Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antidiarrheals
Gastrointestinal Agents
Therapeutic Uses
Cathartics

ClinicalTrials.gov processed this record on May 16, 2013