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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01252524
Recruitment Status : Completed
First Posted : December 3, 2010
Last Update Posted : September 3, 2012
Sponsor:
Information provided by (Responsible Party):
Tae Joon Lee, East Carolina University

Brief Summary:
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 or disease Intervention/treatment
Diabetes Mellitus Type II Drug: Placebo Drug: Calcium polycarbophil

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Calcium Polycarbophil on Type II Diabetes Mellitus Control: a Randomized Double-blind Study
Study Start Date : October 2010
Primary Completion Date : April 2011
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Change in Hemoglobin A1c from baseline [ Time Frame: Enrollment, 3 months, 6 months ]
    Change in hemoglobin A1c will be measured during these time intervals to determine the effects of polycarbophil on diabetes mellitus control.


Secondary Outcome Measures :
  1. Weight [ Time Frame: Baseline, 3 months, 6 months ]
  2. Blood Pressure [ Time Frame: Baseline, 3 months, 6 months ]
  3. Number and dosage of medications for DM, HTN, and hyperlipidemia [ Time Frame: Baseline, 3 months, 6 months ]
  4. Serum LDL, HDL, triglycerides, total cholesterol [ Time Frame: Baseline, 3 months, 6 months ]
  5. Adverse outcomes [ Time Frame: 3 months, 6 months ]
    GI discomfort, constipation, excessive flatulence, fecal impaction, diarrhea, nausea, vomiting, hypoglycemia, other reported side effects.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 3, 2010    Key Record Dates
Last Update Posted: September 3, 2012
Last Verified: August 2012

Keywords provided by Tae Joon Lee, 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
Antidiarrheals
Gastrointestinal Agents
Cathartics