An Investigation Into The Anti-hypertensive And Potential Anti-inflammatory Actions Of Dapagliflozin
1 other identifier
interventional
52
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 type-2-diabetes
Started Nov 2015
Typical duration for phase_4 type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2015
CompletedFirst Posted
Study publicly available on registry
May 5, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedResults Posted
Study results publicly available
October 30, 2019
CompletedOctober 30, 2019
October 1, 2019
2.3 years
April 24, 2015
October 3, 2019
October 29, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Difference in the Percent Change in Fasting Nuclear Factor Kappa-light-chain-enhancer of Activated B Cells Activation (DNA Binding Activity) in Mononuclear Cells Before and After Dapagliflozin Use
nuclear factor kappa-light-chain-enhancer of activated B cells measurement through Transcription factor assay
12 weeks
Secondary Outcomes (6)
Changes in Expression of Inflammatory Mediators
12 Weeks
Changes in Expression of Inflammatory Mediators
12 weeks
Changes in Expression of Inflammatory Mediators
12 weeks
Changes in Expression of Inflammatory Mediators
12 weeks
Changes in Expression of Inflammatory Mediators
12 weeks
- +1 more secondary outcomes
Other Outcomes (7)
Change in Hypertension Mediators
12 weeks
Change in Hypertension Mediators
12 weeks
Change in Hypertension Mediators
12 weeks
- +4 more other outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORPatients will be treated for 12 weeks with placebo once daily
Dapagliflozin
ACTIVE COMPARATOR10 mg daily for the 12 weeks
Interventions
SGLT-2 inhibitor for the treatment of type 2 diabetes
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University at Buffalolead
- Kaleida Healthcollaborator
Study Sites (1)
ECMC Ambulatory Center, 3rd Floor
Buffalo, New York, 14215, United States
Related Publications (1)
Ghanim H, Abuaysheh S, Hejna J, Green K, Batra M, Makdissi A, Chaudhuri A, Dandona P. Dapagliflozin Suppresses Hepcidin And Increases Erythropoiesis. J Clin Endocrinol Metab. 2020 Apr 1;105(4):dgaa057. doi: 10.1210/clinem/dgaa057.
PMID: 32044999DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Paresh Dandona
- Organization
- University at Buffalo
Study Officials
- PRINCIPAL INVESTIGATOR
Paresh Dandona, MD, PhD
University at Buffalo
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- distinguished professor
Study Record Dates
First Submitted
April 24, 2015
First Posted
May 5, 2015
Study Start
November 1, 2015
Primary Completion
March 1, 2018
Study Completion
November 1, 2018
Last Updated
October 30, 2019
Results First Posted
October 30, 2019
Record last verified: 2019-10