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Randomized Trial Comparing N of 1 Trials to Standard Practice to Improve Adherence to Statins in Patients With Diabetes

Primary Purpose

Diabetes, Cardiovascular Disease, Hyperlipidemia

Status
Terminated
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
N of 1 Trials
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes focused on measuring N of 1 trial, diabetes mellitus, HMG CoA Reductase Inhibitors, cardiovascular disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Established diagnosis of type 1 or 2 diabetes Age 18-80 years Indication for a statin by the 2003 Canadian Diabetes Association (CDA) Clinical Practice Guidelines Willingness to re-try a statin despite previous apparent intolerance Provision of signed informed consent Exclusion Criteria: Contraindication to a statin: previous rhabdomyolysis, active liver disease or unexplained persistent elevations of serum transaminases (CK, AST, ALT >three times upper limit of normal), pregnancy or lactation Impaired renal function: severe renal insufficiency (creatinine clearance <30 ml/min) Presence of a condition such as malignancy for which the one-year prognosis is poor Inability of the patient to comply with the rigorous conditions of the trial Any other condition deemed to render the study harmful to the participant

Sites / Locations

  • St. Joseph's Health Care London

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

1

2

Arm Description

N of 1 trials of statin therapy

usual care

Outcomes

Primary Outcome Measures

mean LDL levels

Secondary Outcome Measures

the proportions of participants taking statins at the end of the trial

Full Information

First Posted
March 2, 2006
Last Updated
January 4, 2008
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00299169
Brief Title
Randomized Trial Comparing N of 1 Trials to Standard Practice to Improve Adherence to Statins in Patients With Diabetes
Official Title
Randomized Trial Comparing N of 1 Trials to Standard Practice to Improve Adherence to Statins in Patients With Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Terminated
Why Stopped
insufficient recruitment/enrollment
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients who are intolerant of statins in routine practice, but who lack objective evidence of significant harm, will be randomized to receive statins by either n of 1 trials or standard practice. Our hypothesis is that n of 1 trials will improve statin adherence, thereby improving low density lipoprotein cholesterol (LDL-C) levels.
Detailed Description
Cholesterol lowering medications called "statins" decrease heart disease in people with diabetes but research shows that many patients are not taking these medications, sometimes because of side effects. In our experience, the side effects attributed to statin therapy are often subjective, non-specific, and not associated with objective evidence for a clinically important problem. The most common example is muscle cramps despite a normal CK level, but other symptoms include fatigue, GI intolerance, and neurological symptoms. Traditionally, the effects of treatments are determined using randomized controlled trials. N of 1 trials minimize these biases through randomization, double-blinding, and multiple crossovers, and are therefore excellent tools to evaluate adverse effects of therapies when symptoms are non-specific and objective evidence for a causal relationship is ambiguous. Patients who are intolerant of statins in routine practice, but who lack objective evidence of significant harm, will be randomized to receive statins by either n of 1 trials or standard practice. Our hypothesis is that n of 1 trials will improve statin adherence, thereby improving low density lipoprotein cholesterol (LDL-C) levels. Patients in the n of 1 trials group will be given 1 month courses of either simvastatin or placebo. Patients in the group who are receiving statins according to standard practice will be given a prescription by the doctor in the usual way. At the end of the study, we will determine if more patients participating in n of 1 trials group are taking statins compared to the patients in the conventional group and if this leads to lower cholesterol levels. We plan to use the results of this small feasibility study to test the methods and to plan a larger study on the same question.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Cardiovascular Disease, Hyperlipidemia
Keywords
N of 1 trial, diabetes mellitus, HMG CoA Reductase Inhibitors, cardiovascular disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
N of 1 trials of statin therapy
Arm Title
2
Arm Type
Other
Arm Description
usual care
Intervention Type
Behavioral
Intervention Name(s)
N of 1 Trials
Other Intervention Name(s)
usual care
Intervention Description
N of 1 Trials of statin therapy
Primary Outcome Measure Information:
Title
mean LDL levels
Time Frame
end of study
Secondary Outcome Measure Information:
Title
the proportions of participants taking statins at the end of the trial
Time Frame
end of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Established diagnosis of type 1 or 2 diabetes Age 18-80 years Indication for a statin by the 2003 Canadian Diabetes Association (CDA) Clinical Practice Guidelines Willingness to re-try a statin despite previous apparent intolerance Provision of signed informed consent Exclusion Criteria: Contraindication to a statin: previous rhabdomyolysis, active liver disease or unexplained persistent elevations of serum transaminases (CK, AST, ALT >three times upper limit of normal), pregnancy or lactation Impaired renal function: severe renal insufficiency (creatinine clearance <30 ml/min) Presence of a condition such as malignancy for which the one-year prognosis is poor Inability of the patient to comply with the rigorous conditions of the trial Any other condition deemed to render the study harmful to the participant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlotte G McDonald, MD
Organizational Affiliation
Western University, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Health Care London
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada

12. IPD Sharing Statement

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Randomized Trial Comparing N of 1 Trials to Standard Practice to Improve Adherence to Statins in Patients With Diabetes

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