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

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.