An Investigation Into The Anti-hypertensive And Potential Anti-inflammatory Actions Of Dapagliflozin
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 20 - 80 |
| Updated: | 4/21/2016 |
| Start Date: | November 2015 |
| End Date: | May 2018 |
| Contact: | Paresh Dandona, MD |
| Email: | pdandona@kaleidahealth.org |
| Phone: | 7168981950 |
This is a single center, prospective, randomized, placebo -controlled, parallel design and
double blind study to evaluate oxidative stress, inflammation and hypertension markers and
mediators before and after treatment with dapagliflozin.
double blind study to evaluate oxidative stress, inflammation and hypertension markers and
mediators before and after treatment with dapagliflozin.
Two groups of 26 patients each (total 52 patients) with type 2 diabetes on oral agents will
be included in the study. One group will be randomized to dapagliflozin (a dose of 5 mg
daily will be titrated to 10 mg daily during the first week) while the other will be
placebo. The patients will be treated for 12 weeks. Only half the patients (equal numbers in
both groups) will be tested for the secondary endpoints related to postprandial and single
dose induced changes. The primary endpoint of the study is to detect a significant
difference in the percent change in fasting Nuclear factor-k B (NFκB) activation (DNA
binding activity) in mononuclear cells (MNC) before and after dapagliflozin use (0 week vs.
12 weeks) as compared to placebo.
be included in the study. One group will be randomized to dapagliflozin (a dose of 5 mg
daily will be titrated to 10 mg daily during the first week) while the other will be
placebo. The patients will be treated for 12 weeks. Only half the patients (equal numbers in
both groups) will be tested for the secondary endpoints related to postprandial and single
dose induced changes. The primary endpoint of the study is to detect a significant
difference in the percent change in fasting Nuclear factor-k B (NFκB) activation (DNA
binding activity) in mononuclear cells (MNC) before and after dapagliflozin use (0 week vs.
12 weeks) as compared to placebo.
Inclusion Criteria:
- Age 20-80 years inclusive.
- Type 2 diabetes
- BMI ≥30 kg/m2
- Subjects on statins, ACE inhibitors, ARBs, thiazolidinediones and -antioxidants will
be allowed as long as they are on stable doses of these -compounds and the dosage in
not changed during the course of study. -Patients will be evenly distributed between
the 2 groups based on statins, -ARBs, TZDs and ACE inhibitors use.
- HbA1c ≤ 8.0%
Exclusion Criteria:
- Use of GLP-1 agonists or DPP-IV or SGLT-2 inhibitors therapy in the last 3 -months.
- Risk for pancreatitis, i.e., history of gallstones, alcohol abuse, and
-hypertriglyceridemia.
- Coronary event or procedure (myocardial infarction, unstable angina, coronary -artery
bypass, surgery or coronary angioplasty) in the previous 3 months.
- Hepatic disease: Severe hepatic insufficiency and/or significant abnormal liver
-function defined as:
- aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or -alanine
aminotransferase (ALT) >3x ULN
- Total bilirubin >2.0 mg/dL (34.2 µmol/L)
- Positive serologic evidence of current infectious liver disease including Hepatitis B
viral antibody IGM, Hepatitis B surface antigen and Hepatitis C virus antibody
- (liver function tests more than 3 times the upper limit of normal)
- Renal impairment (serum eGFR <60 ml/min)
- Any other life-threatening, non-cardiac disease
- Uncontrolled hypertension (BP > 160/100 mm of Hg)
- Congestive Heart Failure class III or IV.
- Use of an investigational agent or therapeutic regimen within 30 days of study
- Participation in any other concurrent clinical trial
- pregnant or breastfeeding patients
- Volume depleted patients. Patients at risk for volume depletion due to co-existing
conditions or concomitant medications, such as loop diuretics
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