Vascular Function, Endothelin, and Inflammation in Pre-diabetic Obesity Versus Lean Healthy Controls
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|ClinicalTrials.gov Identifier: NCT00837590|
Recruitment Status : Completed
First Posted : February 5, 2009
Last Update Posted : May 22, 2012
We intend to pursue the following Aims:
- Does inflammation contribute importantly to concurrent defects in vascular and metabolic dysfunction in human pre-diabetic obesity?
- Are there benefits of anti-inflammatory treatment strategies in pre-diabetic obesity in the context of existing treatment with metformin?
- Are there benefits of anti-inflammatory treatment strategies in pre-diabetic obesity in the context of existing treatment with lisinopril?
The intent of the current project is to efficiently and at low cost generate preliminary data along each of these lines of questioning, studying the minimum number of subjects required to assess the viability of the question using the current measurement approaches.
|Condition or disease||Intervention/treatment|
|Pre-diabetes Obesity||Drug: salsalate Drug: metformin Drug: lisinopril|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Vascular Function, Endothelin, and Inflammation in Pre-diabetic Obesity Versus Lean Healthy Controls|
|Study Start Date :||March 2009|
|Primary Completion Date :||June 2010|
|Study Completion Date :||August 2010|
Nondiabetic lean and obese subjects will be studied in this arm. Subjects will be studied at baseline and after 2 months of treatment with salsalate.
Subjects will receive 2 months of treatment with 4 gram/day of oral salsalate divided into 3 doses.
Obese subjects will be pre-treated with metformin 1000mg bid for 4 weeks prior to baseline measurements and will continue metformin in addition to salsalate for an additional 2 months.
Subjects will receive 2 months of treatment with 4 gram/day of oral salsalate divided into 3 doses.Drug: metformin
metformin po 1000mg bid
Obese subjects will be pre-treated with lisinopril 20mg qd for 4 weeks prior to baseline measurements and continue lisinopril in addition to salsalate for an additional 2 months.
Subjects will receive 2 months of treatment with 4 gram/day of oral salsalate divided into 3 doses.Drug: lisinopril
lisinopril po 20mg qd
- The primary endpoints of interest are basal flow and diameter, flow-mediated vasodilation, insulin-stimulated glucose disposal and insulin-mediated vasodilation measured by brachial artery ultrasound [ Time Frame: End of study ]
- Other endpoints of interest include circulating levels of endothelin and nitric oxide, levels of inflammatory markers, circulating endothelial progenitor cell numbers, and steady-state glucose disposal rate for the insulin infusion study. [ Time Frame: End of study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00837590
|United States, Indiana|
|Indiana Clinical Research Center|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Kieren J Mather, MD||Indiana University|