Pre-diabetesPhase 1NCT00837590
Vascular Function, Endothelin, and Inflammation in Pre-diabetic Obesity Versus Lean Healthy Controls
A Phase 1 study testing Chronic salsalate and Acute Salsalate in people with Pre-diabetes and Obesity, run by Indiana University at 1 site in United States.
Trial summary
Aims: 1. Does inflammation contribute importantly to concurrent defects in vascular and metabolic dysfunction in human pre-diabetic obesity? 2. Are there benefits of anti-inflammatory treatment strategies in pre-diabetic obesity in the context of existing treatment with metformin? 3. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre-diabetes, Obesity
- What is being tested?
- Chronic salsalate and Acute Salsalate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Aug 2010
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- normotensive (BP<140/95 mmHg)
- lean and obese
- 18 and 55 years
- women must be premenopausal
Who cannot join
- use of pharmacologic agents or recreational drugs, with the exception of occasional use of non-narcotic pain medications
- blood pressure (>140/90 mmHg)
- elevated cholesterol (LDL >130 mg/dL)
- diabetes mellitus (by ADA criteria)
- evidence of coronary and/or peripheral vascular disease by history and physical exam
- >5 kg change in weight in the preceding 3 months
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- chronic systemic illness with recognized metabolic effects
- hepatitis C and HIV
- recognized systemic inflammatory or autoimmune processes such as rheumatoid arthritis or systemic lupus erythematosis
- Raynaud's phenomenon or other abnormalities of hand or finger perfusion
- regular participation in endurance or high-performance athletic activity
- history of aspirin or salsalate sensitivity including aspirin-induced asthma
- prior treatment with salsalate, pentoxyfilline, or monoclonal anti-TNFalpha antibodies
- pregnancy
- liver transaminase levels >3 times the upper limit of normal
- creatinine >1.5 mg/dL
- history of a cellular immunodeficiency-related opportunistic infections, such as an endemic mycosis (eg. histoplasmosis) or mycobacterial infection (eg tuberculosis)
- reactive tuberculin skin test
- history of malignancy except for basal cell carcinoma of the skin
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana Clinical Research Center
Indianapolis, Indiana, 46202
About this study
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?
Read the detailed description
We set out to pursue the following Aims:
- Does inflammation contribute importantly to concurrent defects in vascular and metabolic dysfunction in human pre-diabetic obesity? Pilot studies were performed exploring the acute actions of salsalate on vascular function, the chronic actions of salasate in obese individuals, and actions of chronic salsalate to prevent vascular dysfunction induced by fatty acids in lean individuals.
- Are there benefits of anti-inflammatory treatment strategies in pre-diabetic obesity in the context of existing treatment with metformin? No studies were performed
- Are there benefits of anti-inflammatory treatment strategies in pre-diabetic obesity in the context of existing treatment with lisinopril? No studies were performed
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.
- Conditions
- Pre-diabetes, Obesity
- Being tested
- Chronic salsalate, Acute Salsalate
- Keywords
- Vascular function, Glucose tolerance, Obesity, Pre-diabetes
- Medical subject headings
- Glucose Intolerance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic salsalateDrug
Subjects will receive 2 months of treatment with 4 gram/day of oral salsalate divided into 3 doses.
Acute SalsalateDrug
Subjects will receive a single oral dose of 2 gram of oral salsalate
| Study group | Role | What they receive |
|---|---|---|
| Acute Salsalate | Experimental | Nondiabetic lean and obese subjects will be studied in this arm. Subjects will be studied at baseline and after a single dose of oral salsalate. Receives: Drug: Acute Salsalate |
| Chronic Salsalate - Obese | Experimental | Obese subjects will be studied in this arm. Subjects will be studied at baseline and after 2 months' treatment with oral salsalate. Receives: Drug: Chronic salsalate |
| Chronic Salsalate - Lean | Experimental | Lean subjects will be studied in this arm. Subjects will be studied at baseline and after 2 months' treatment with oral salsalate. The effects of an acute fatty acid infusion on vascular function will be measured on both occasions. Receives: Drug: Chronic salsalate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular Function
The primary endpoints of interest is flow-mediated vasodilation
Measured: Measured at baseline and after a single oral dose of salsalate (Acute) or 2 months' treatment with salsalate (Chronic)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionJun 2010
- Study completionAug 2010
Why it stopped: Preliminary results indicated no measurable benefit.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pre-diabetesStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kieren J Mather, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00837590
- Sponsor's protocol ID
- IU-IRB-0901-03
- Status last verified
- May 2013
- First submitted
- 4 Feb 2009
- Last updated
- 1 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Function, Endothelin, and Inflammation in Pre-diabetic Obesity Versus Lean Healthy Controls
- ClinicalTrials.gov ID
- NCT00837590
- Acronym / sponsor ID
- IU-IRB-0901-03
- Conditions
- Pre-diabetes, Obesity
- Keywords
- Vascular function, Glucose tolerance, Obesity, Pre-diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Preliminary results indicated no measurable benefit.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 5 Feb 2009 (estimated)
- Results
- Posted 1 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
We set out to pursue the following Aims:
- Does inflammation contribute importantly to concurrent defects in vascular and metabolic dysfunction in human pre-diabetic obesity? Pilot studies were performed exploring the acute actions of salsalate on vascular function, the chronic actions of salasate in obese individuals, and actions of chronic salsalate to prevent vascular dysfunction induced by fatty acids in lean individuals.
- Are there benefits of anti-inflammatory treatment strategies in pre-diabetic obesity in the context of existing treatment with metformin? No studies were performed
- Are there benefits of anti-inflammatory treatment strategies in pre-diabetic obesity in the context of existing treatment with lisinopril? No studies were performed
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acute Salsalate | Experimental | Drug: Acute SalsalateNondiabetic lean and obese subjects will be studied in this arm. Subjects will be studied at baseline and after a single dose of oral salsalate. |
| Chronic Salsalate - Obese | Experimental | Drug: Chronic salsalateObese subjects will be studied in this arm. Subjects will be studied at baseline and after 2 months' treatment with oral salsalate. |
| Chronic Salsalate - Lean | Experimental | Drug: Chronic salsalateLean subjects will be studied in this arm. Subjects will be studied at baseline and after 2 months' treatment with oral salsalate. The effects of an acute fatty acid infusion on vascular function will be measured on both occasions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- healthy
- normotensive (BP<140/95 mmHg)
- lean and obese
- 18 and 55 years
- women must be premenopausal
Key exclusion criteria (19 listed)
- use of pharmacologic agents or recreational drugs, with the exception of occasional use of non-narcotic pain medications
- blood pressure (>140/90 mmHg)
- elevated cholesterol (LDL >130 mg/dL)
- diabetes mellitus (by ADA criteria)
- evidence of coronary and/or peripheral vascular disease by history and physical exam
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chronic salsalateSubjects will receive 2 months of treatment with 4 gram/day of oral salsalate divided into 3 doses. | Drug | Chronic Salsalate - Lean, Chronic Salsalate - Obese |
| Acute SalsalateSubjects will receive a single oral dose of 2 gram of oral salsalate | Drug | Acute Salsalate |
Primary outcome
Vascular Function
Time frame: Measured at baseline and after a single oral dose of salsalate (Acute) or 2 months' treatment with salsalate (Chronic)
The primary endpoints of interest is flow-mediated vasodilation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kieren J Mather, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Chronic salsalate and Acute Salsalate in people with Pre-diabetes and Obesity, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular Function (time frame: Measured at baseline and after a single oral dose of salsalate (Acute) or 2 months' treatment with salsalate (Chronic)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2019.