Colesevelam, Lipids And Sugars, South Asian Canadian Trial

NCT02504736 | Completed

• 1 other identifier: CLASS ACT-24-FEB-2015
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effect of colesevelam on LDL levels and A1c in high-risk , dysglycemic South Asians (with diabetes, and/or with CAD and concomitant metabolic syndrome) whose LDL remains above target despite optimal statin use.

Conditions

Dyslipidemia

Keywords

LDL cholesterol; A1c; High risk South Asians; Colesevelam

Outcome Measures

Primary Outcomes (1)

• The % difference in LDL between baseline and end of study

  6 months

Secondary Outcomes (3)

• The % change in HbA1c levels between baseline and end of study

  6 months

• The absolute change in LDL and non-HDL levels between baseline and end of study

  6 months

• The safety and tolerability of colesevelam will be determined by the patient reported side/adverse effects and/or hospitalization related to Colesevelam. The side effects will be captured at Visit 3, 4 and 5.

  6 months

Eligibility Criteria

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

Study Population

Individuals of South Asian ethnicity; self-declared, at least 3 of 4 grandparents born in a South Asian country (i.e. India, Pakistan, Bangladesh, Sri Lanka, Nepal and Bhutan)

You may qualify if:

• Individuals of South Asian ethnicity; self-declared, at least 3 of 4 grandparents born in a South Asian country (i.e. India, Pakistan, Bangladesh, Sri Lanka, Nepal and Bhutan)
• Either Diabetes, or Coronary artery disease with metabolic syndrome
• Currently receiving maximally tolerated dose of statin therapy (at least Atorvastatin 20 mg or Rosuvastatin 10 mg)
• LDL \>2.0 mmol/L or non-HDL \>2.6 mmol/L
• Patient is willing to provide written consent
• Age ≥ 18 years

You may not qualify if:

• Receiving lipid-lowering agents, other than statins or ezetimibe
• Any changes made to current lipid lowering therapy in the last 12 weeks
• Uncontrolled diabetes (HbA1c \>0.10)
• TG \> 5.0 mmol/L
• Significant hepatic or renal disease (ALT \> 2x ULN or eGFR \< 30 mL/min/1.73 m²)
• Ongoing participation in any randomized clinical trial

Sponsors & Collaborators

• Canadian Collaborative Research Network: lead
• Valeant Canada Limited: collaborator

Study Sites (1)

Dr. Milan Gupta,MD

Brampton, Ontario, L6Z 4N5, Canada

Location

Related Publications (7)

• Corsini A, Windler E, Farnier M. Colesevelam hydrochloride: usefulness of a specifically engineered bile acid sequestrant for lowering LDL-cholesterol. Eur J Cardiovasc Prev Rehabil. 2009 Feb;16(1):1-9. doi: 10.1097/HJR.0b013e32831215db.

  PMID: 19237992 BACKGROUND

• Aggarwal S, Loomba RS, Arora RR. Efficacy of colesevelam on lowering glycemia and lipids. J Cardiovasc Pharmacol. 2012 Feb;59(2):198-205. doi: 10.1097/FJC.0b013e31823a109f.

  PMID: 21983746 BACKGROUND

• Goldberg RB. Improving glycemic and cholesterol control through an integrated approach incorporating colesevelam - a clinical perspective. Diabetes Metab Syndr Obes. 2009 May 5;2:11-21. doi: 10.2147/dmsott.s3866.

  PMID: 21437115 BACKGROUND

• Brunetti L, DeSantis EH. Patient tolerance and acceptance of colesevelam hydrochloride: focus on type-2 diabetes mellitus. P T. 2015 Jan;40(1):62-7.

  PMID: 25628509 BACKGROUND

• Jialal I, Abby SL, Misir S, Nagendran S. Concomitant reduction in low-density lipoprotein cholesterol and glycated hemoglobin with colesevelam hydrochloride in patients with type 2 diabetes: a pooled analysis. Metab Syndr Relat Disord. 2009 Jun;7(3):255-8. doi: 10.1089/met.2009.0007.

  PMID: 19344229 BACKGROUND

• Fonseca VA, Rosenstock J, Wang AC, Truitt KE, Jones MR. Colesevelam HCl improves glycemic control and reduces LDL cholesterol in patients with inadequately controlled type 2 diabetes on sulfonylurea-based therapy. Diabetes Care. 2008 Aug;31(8):1479-84. doi: 10.2337/dc08-0283. Epub 2008 May 5.

  PMID: 18458145 BACKGROUND

• Zieve FJ, Kalin MF, Schwartz SL, Jones MR, Bailey WL. Results of the glucose-lowering effect of WelChol study (GLOWS): a randomized, double-blind, placebo-controlled pilot study evaluating the effect of colesevelam hydrochloride on glycemic control in subjects with type 2 diabetes. Clin Ther. 2007 Jan;29(1):74-83. doi: 10.1016/j.clinthera.2007.01.003.

  PMID: 17379048 BACKGROUND

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Milan K Gupta, MD

  McMaster University, Hamilton, ON Canada; University of Toronto, Toronto, ON Canada

  PRINCIPAL INVESTIGATOR

• Narendra Singh, MD

  Georgia Regents University, Georgia, US

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2015
• First Posted: July 22, 2015
• Study Start: June 1, 2015
• Primary Completion: February 15, 2018
• Study Completion: February 28, 2018
• Last Updated: January 23, 2020

Record last verified: 2020-01

Locations

CA (1)