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

August 31, 2012 updated by: Tae Joon Lee, East Carolina University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There have been several publications in the medical literature linking the use of various types of fiber and the beneficial effects on lipid panel, glycosylated hemoglobin A1c, weight, blood pressure, and cardiovascular events in patients with type 2 diabetes mellitus or those at risk for diabetes1-5. Most of these studies utilize fiber sources from dietary food intake or psyllium.

However, diet modification and psyllium intake are difficult for patients to comply on daily basis and many patients do not continue to follow through on these interventions.

Polycarbophil is a bulk forming agent which is used for similar indications as psyllium for the treatment of constipation and irritable bowel syndrome. Because polycarbophil comes in oral tablets and capsules, patients may adhere to regular intake better compared to psyllium. However, it is unknown whether polycarbophil has similar beneficial properties compared to psyllium and other fiber types. Taking polycarbophil prior to each meal may improve diabetes control by allowing patients to have smaller meals and decrease the absorption rate of carbohydrates in the intestine.

The goal of this study is to determine whether taking calcium polycarbophil (also known as over-the-counter FiberconTM) regularly will improve the diabetes control. The proposed study will be a randomized, controlled, and double-blinded trial involving adult patients with type 2 diabetes mellitus. A total of 50 patients will be randomized to receive either calcium polycarbophil or placebo from the Family Medicine Center at East Carolina University and followed over 6 months. The primary outcome of the trial will be glycosylated hemoglobin A1c. Secondary outcome measures will include weight, blood pressure, and cholesterol level. Additional secondary outcome measures are the number and dosages of medications for diabetes mellitus, hypertension, and hyperlipidemia.

The potential benefits of this study include improved control of diabetes mellitus, hypertension, and hyperlipidemia, reflected by the improved outcomes mentioned above. Because calcium polycarbophil (FiberconTM) is a commonly used over-the-counter fiber product for constipation, and the dosage used in this study is well within the typical use recommended by the manufacturers, the potential adverse effects of this product is thought to be identical to that described for FiberconTM. Patients will receive their usual medical care by their own primary physicians regardless of their participation in this study. After the randomization to the intervention or the control group, the study team will only monitor the outcome measures and will not alter the medical care that the patients receive.

Study title:

Effects of calcium polycarbophil on type II diabetes mellitus control: a randomized double-blinded study.

Patient population:

East Carolina University Family Medicine Center (ECU FMC) outpatient clinic patients Age above 18 Diagnosed with type II diabetes mellitus (DM) for at least 24 months. At least 4 office visits within the past 24 months for DM follow up at ECU FMC or Geriatrics Center.

Hgb A1c within the past six months of 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 (i.e. fecal impaction) Dysphagia or other swallowing disorders (unable to swallow pills or 8 oz of water) Pregnancy during the study period

Consent:

Will be obtained from the patients for the study and HIPAA.

Study design:

Randomize 50 patients to intervention or placebo:

Intervention: 25 patients to receive calcium polycarbophil 625mg po TID before each meal with 8 oz glass of water for 6 months.

Placebo control: 25 patients to receive placebo po TID before each meal with 8 oz glass of water for 6 months.

Total of 50 participants projected from the following power calculation:

Assuming a difference between groups in HbA1c of 0.5%, a standard deviation of 0.5, a power of 80% and an alpha of 0.05, an estimated 18 patients in each group (n = 36 pts) will be needed to detect a difference. Assuming a 25% dropout rate, the goal of 25 patients in each group (n=50 pts) will be needed.

Patients, primary physicians, and the researchers will be blinded to therapy versus placebo. Randomization will be performed by the ECU FM pharmacist who will open a sealed envelope which will indicate whether the patient will receive the interventional medication or placebo. The tablets will be dispensed by the pharmacist without informing the patient, physicians, or research team member as to which group the patient was randomized.

All patient will continue with their usual DM care. The patients must follow up at 3 months and 6 months.

A research team member will perform telephone follow up at 1 week, 1 month, and 3 months for adverse events and compliance.

The outcomes will be analyzed by intention to treat analysis and analysis using patients who are compliant with the trial protocol.

Primary outcome:

HgbA1c at the time of enrollment, 3 months, and 6 months.

Secondary outcome:

Data will be gathered at the time of enrollment, 3 months, and 6 months:

Weight Blood Pressure Number and dosage of medications for diabetes, hypertension, and hyperlipidemia Serum LDL, HDL, triglycerides, total cholesterol Patient compliance with the study medication Adverse events including GI discomfort, constipation, excessive flatulence, fecal impaction, diarrhea, nausea, vomiting, hypoglycemia, etc.

Potential adverse events:

Side effects of Polycarbophil (MicroMedex 2.0): Abdominal fullness, flatus, vomiting, stomach cramps. Systemic adverse effects are not expected since calcium polycarbophil is not absorbed

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • East Carolina University Family Medicine Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Enrollment, 3 months, 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

East Carolina University

Investigators

  • Principal Investigator: Tae J Lee, MD, CMD, East Carolina University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

November 5, 2010

First Submitted That Met QC Criteria

December 2, 2010

First Posted (Estimate)

December 3, 2010

Study Record Updates

Last Update Posted (Estimate)

September 3, 2012

Last Update Submitted That Met QC Criteria

August 31, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-0422

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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