Clinical trial NCT00795262: Effects of Quinapril 40 mg With Alpha Lipoic Acid or Placebo on Diabetes and Hypertension
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Hypertension
Keywords: brachial artery reactivity
Lead sponsor: InVasc Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2008-11-21
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

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 criteria: 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

1. Abstinence, meaning a total lack of any sexual activity.
2. Oral contraceptives (the "pill"),
3. Contraceptive injections,
4. Intrauterine device,
5. Double-barrier method (diaphragm or condom + spermicidal cream),
6. Contraceptive patch, or
7. 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.

Primary outcomes:
measure: 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.
timeFrame: 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).
Secondary outcomes:
measure: 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
timeFrame: at baseline (week-1), weeks 8, 12 and 20.
Other outcomes:
Locations:
city: Tucker
country: United States
facility: Atlanta Vascular Research Foundation
state: Georgia
Study officials:
affiliation: Atlanta Vascular Research Foundation
name: Syed T. Rahman, MD
role: PRINCIPAL_INVESTIGATOR
References: