Effects of Quinapril 40 mg With Alpha Lipoic Acid or Placebo on Diabetes and Hypertension (QUALITY)
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Purpose
We will evaluate the combination of quinapril and alpha lipoic acid in patients with diabetes mellitus and hypertension. We will determine whether the combination of quinapril and lipoic acid as compared to quinapril and placebo provides benefit on systemic blood pressure and proteinuria.
| Condition | Intervention |
|---|---|
|
Diabetes Hypertension |
Drug: Quinapril (Accupril) plus Alpha Lipoic Acid Drug: accupril, placebo Drug: accupril, alpha lipoic acid |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A 22-week Randomized, Cross-over Study Comparing the Effects of Quinapril and Quinapril Plus Alpha-lipoic Acid (ALA) on Patients With Diabetes Mellitus and Hypertension |
- Comparison of relative change of systolic BP/diastolic BP and urinary albumin excretion from baseline in diabetic patients treated with quinapril plus lipoic acid versus quinapril and placebo. [ Time Frame: The total study period is 22 weeks i.e. the initial prescreening visit followed 1 week later by the baseline study visit, 8 weeks of treatment (Treatment A or B), 4 weeks washout, 8 weeks of treatment (Treatment A or B). ] [ Designated as safety issue: No ]
- Comparison of patients treated with quinapril plus lipoic acid versus quinapril plus placebo in the following areas: a) Changes from baseline in high sensitivity C-reactive protein, adiponectin, and leptin [ Time Frame: at baseline (week-1), weeks 8, 12 and 20. ] [ Designated as safety issue: No ]
| Enrollment: | 23 |
| Study Start Date: | July 2008 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: placebo comparator
Quinapril 40 mg (Accupril)plus placebo will be given for 8 weeks.
|
Drug: accupril, placebo
accupril 40 mg
Other Names:
|
|
Active Comparator: Active comparator
Quinapril 40 mg plus Alpha Lipoic Acid (ALA)on vascular effects of patients with diabetes and hypertension
|
Drug: Quinapril (Accupril) plus Alpha Lipoic Acid
Patients in Arm 2 (n=20) will receive quinapril 40 mg and Alpha Lipoic Acid (600 mg/day)for an 8-week treatment period (Treatment A).
Other Names:
Drug: accupril, alpha lipoic acid
accupril (quinapril) 40 mg plus alpha lipoic acid 600 mg
Other Names:
|
Detailed Description:
The participant will be randomized to either quinapril 40 mg and alpha lipoic acid versus quinapril 40 mg and placebo for 8 weeks. There will be a wash out period of 4 weeks between the cross over. The participant will be assigned the cross over for 8 weeks on the opposite therapy.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients who have a diagnosis of diabetes mellitus as defined by fasting blood glucose levels greater than ot equal to 126mg/dL and a systolic BP greater than 125 mm Hg at the time of screening will be included in the study. Patients may be on antihypertensive medication but not on ACE inhibitor or ARB therapy at the time of enrollment.
Exclusion Criteria:
Systolic blood pressure > 180 mmHg Creatinine > 2.5 mg/dl Glycosylated hemoglobin > 7.5% Congestive heart failure (NYHA Class II, III or IV) Coronary angiography planned prior to baseline sampling Chronic autoimmune disease Chronic inflammatory disease or known cancer in evolution life expectancy < 1 year Immunosuppressives or treatment with any other investigational drug within the last 30 days Pregnant or nursing women Participants who experience any side effects to quinapril and/or alpha lipoic acid
Women of childbearing potential Women of childbearing potential enrolled in the study should use one of the acceptable methods of birth control as listed below
- Abstinence, meaning a total lack of any sexual activity.
- Oral contraceptives (the "pill"),
- Contraceptive injections,
- Intrauterine device,
- Double-barrier method (diaphragm or condom + spermicidal cream),
- Contraceptive patch, or
- Male partner sterilization.
Pregnancy Any pregnancy that occurs during study participation must be reported to the Principal Investigator and the study coordinator at the earliest. The pregnancy must be followed up to determine outcome and status of the mother and child. To ensure subject safety, any subject that becomes pregnant during the study will be discontinued from the trial.
Contacts and Locations| United States, Georgia | |
| Atlanta Vascular Research Foundation | |
| Tucker, Georgia, United States, 30084 | |
| Principal Investigator: | Syed T. Rahman, MD | Atlanta Vascular Research Foundation |
More Information
No publications provided
| Responsible Party: | Syed T. Rahman, MD, Atlanta Vascular Research Foundation |
| ClinicalTrials.gov Identifier: | NCT00795262 History of Changes |
| Other Study ID Numbers: | INV-064 QUALITY |
| Study First Received: | November 20, 2008 |
| Last Updated: | May 4, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by InVasc Therapeutics, Inc.:
|
brachial artery reactivity |
Additional relevant MeSH terms:
|
Diabetes Mellitus Hypertension Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Vascular Diseases Cardiovascular Diseases Thioctic Acid Quinapril Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Protective Agents Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients Growth Substances Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors Antihypertensive Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013