drugset / Trial / NCT01252524
Effect of Calcium Polycarbophil on Type II Diabetes Mellitus Control: a Randomized Double-blind Study
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2010-10
- Primary completion
- 2011-04
- Completion
- 2011-04
Publications
- Background 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Calcium polycarbophil | Small molecule | 625 mg | Oral |