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

NCT01252524 | Completed

• 1 other identifier: 10-0422
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus Type II

Keywords

diabetes mellitus; fiber; glycemic control; calcium polycarbophil

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

  3 months, 6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

A placebo tablet PO TID before each meal with 8 oz of water for 6 months.

Drug: Placebo

Calcium polycarbophil

EXPERIMENTAL

Calcium polycarbophil 625 mg PO TID before each meal with 8 oz of water for 6 months

Drug: Calcium polycarbophil

Interventions

Placebo DRUG

Placebo tablet po TID before each meal with 8 oz of water for 6 months

Placebo

Calcium polycarbophil DRUG

calcium polycarbophil 625 mg po TID before each meal with 8 oz water for 6 months

Also known as: Konsyl, Fibercon

Calcium polycarbophil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• East Carolina University: lead

Study Sites (1)

East Carolina University Family Medicine Center

Greenville, North Carolina, 27834, United States

Location

Related Publications (5)

• Chandalia M, Garg A, Lutjohann D, von Bergmann K, Grundy SM, Brinkley LJ. Beneficial effects of high dietary fiber intake in patients with type 2 diabetes mellitus. N Engl J Med. 2000 May 11;342(19):1392-8. doi: 10.1056/NEJM200005113421903.

  PMID: 10805824 BACKGROUND

• Vuksan V, Jenkins DJ, Spadafora P, Sievenpiper JL, Owen R, Vidgen E, Brighenti F, Josse R, Leiter LA, Bruce-Thompson C. Konjac-mannan (glucomannan) improves glycemia and other associated risk factors for coronary heart disease in type 2 diabetes. A randomized controlled metabolic trial. Diabetes Care. 1999 Jun;22(6):913-9. doi: 10.2337/diacare.22.6.913.

  PMID: 10372241 BACKGROUND

• Rodriguez-Moran M, Guerrero-Romero F, Lazcano-Burciaga G. Lipid- and glucose-lowering efficacy of Plantago Psyllium in type II diabetes. J Diabetes Complications. 1998 Sep-Oct;12(5):273-8. doi: 10.1016/s1056-8727(98)00003-8.

  PMID: 9747644 BACKGROUND

• Ziai SA, Larijani B, Akhoondzadeh S, Fakhrzadeh H, Dastpak A, Bandarian F, Rezai A, Badi HN, Emami T. Psyllium decreased serum glucose and glycosylated hemoglobin significantly in diabetic outpatients. J Ethnopharmacol. 2005 Nov 14;102(2):202-7. doi: 10.1016/j.jep.2005.06.042. Epub 2005 Sep 8.

  PMID: 16154305 BACKGROUND

• Ylonen K, Saloranta C, Kronberg-Kippila C, Groop L, Aro A, Virtanen SM; Botnia Dietary Study. Associations of dietary fiber with glucose metabolism in nondiabetic relatives of subjects with type 2 diabetes: the Botnia Dietary Study. Diabetes Care. 2003 Jul;26(7):1979-85. doi: 10.2337/diacare.26.7.1979.

  PMID: 12832299 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

calcium polycarbophil; Psyllium

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Tae J Lee, MD, CMD

  East Carolina University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: November 5, 2010
• First Posted: December 3, 2010
• Study Start: October 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: September 3, 2012

Record last verified: 2012-08

Locations

US (1)