Type 2 Diabetes MellitusPhase 1/2NCT01626469
Measurement of Eye Blood Flow and Renal Function in Healthy and Diabetic Patients
A Phase 1/2 study testing Captopril in people with Type 2 Diabetes Mellitus, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The purpose of this study is to the determine the effect of salt intake and Captopril on the ophthalmic artery (OA) blood supply of individuals with Type 2 Diabetes Mellitus. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Captopril
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Sep 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 Diabetes Mellitus
Who cannot join
- Type 1 Diabetes Mellitus
- Heart Attack or Stroke within the last 6 months
- Pregnant or lactating females
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Eye Blood Flow and the Kidney
The purpose of this study is to the determine the effect of salt intake and Captopril on the ophthalmic artery (OA) blood supply of individuals with Type 2 Diabetes Mellitus.
Read the detailed description
The overall objective of this study is to ascertain if salt intake affects ophthalmic artery (OA) blood flow. In addition, we will study both the eye and kidney response to ACE inhibition compared to placebo while controlling salt intake in subjects with Type 2 diabetes mellitus.
We hypothesize that salt intake will affect OA blood flow.
We will initially look at both eye and renal response to subjects on a low salt diet (10mEq Na/day) followed by response to high salt diet (200mEq Na/day). In addition, we may look at eye response while subjects consume their regular diet.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Captopril, placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaptoprilDrug
25mg Captopril
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Captopril 25 mg (Admission 1, Day 1, low salt diet) Matched Placebo (Admission 1, Day 2, low salt diet) Captopril 25 mg (Admission 2, Day 1, high salt diet) Matched Placebo (Admission 2, Day 2, high salt diet) Receives: Drug: Captopril; Drug: placebo |
| Captopril | Placebo comparator | Matched Placebo (Admission 1, Day 1, low salt diet) Captopril 25 mg (Admission 1, Day 2, low salt diet) Matched Placebo (Admission 2, Day 1, high salt diet) Captopril 25 mg (Admission 2, Day 2, high salt diet) Receives: Drug: Captopril; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ophthalmic artery blood flow from baseline
Eye blood flow will be measured at baseline and post drug time points (3 total)
Measured: 1 hour post drug, 2 hours post drug, 3 hours post drug
Secondary outcomes (2)
Change in blood pressure from baseline
Blood pressure will be monitored throughout the study starting at baseline
Measured: Every 15 minutes for 3 hours
Change in renal plasma flow (RPF) from baseline
Renal Plasma Flow (to measure kidney function) will be measured at baseline and post drug time points (3 total)
Measured: 1 hour post drug, 2 hours post drug, 3 hours post drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norman K. Hollenberg, MD, PhD, Brigham and Women's Hospital
- Investigators
- Norman K Hollenberg, MD, PhD, Principal investigator, Brigham and Women's HospitalEbrahim Barkoudah, M.D.,M.P.H., Study director, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01626469
- Sponsor's protocol ID
- 2011P002805
- Status last verified
- Jul 2019
- First submitted
- 19 Jun 2012
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
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
- Eye Blood Flow and the Kidney
- ClinicalTrials.gov ID
- NCT01626469
- Acronym / sponsor ID
- 2011P002805
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- May 2012 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 22 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to the determine the effect of salt intake and Captopril on the ophthalmic artery (OA) blood supply of individuals with Type 2 Diabetes Mellitus.
Detailed description
The overall objective of this study is to ascertain if salt intake affects ophthalmic artery (OA) blood flow. In addition, we will study both the eye and kidney response to ACE inhibition compared to placebo while controlling salt intake in subjects with Type 2 diabetes mellitus.
We hypothesize that salt intake will affect OA blood flow.
We will initially look at both eye and renal response to subjects on a low salt diet (10mEq Na/day) followed by response to high salt diet (200mEq Na/day). In addition, we may look at eye response while subjects consume their regular diet.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: Captopril, Drug: placeboCaptopril 25 mg (Admission 1, Day 1, low salt diet) Matched Placebo (Admission 1, Day 2, low salt diet) Captopril 25 mg (Admission 2, Day 1, high salt diet) Matched Placebo (Admission 2, Day 2, high salt diet) |
| Captopril | Placebo comparator | Drug: Captopril, Drug: placeboMatched Placebo (Admission 1, Day 1, low salt diet) Captopril 25 mg (Admission 1, Day 2, low salt diet) Matched Placebo (Admission 2, Day 1, high salt diet) Captopril 25 mg (Admission 2, Day 2, high salt diet) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Type 2 Diabetes Mellitus
Key exclusion criteria (3 listed)
- Type 1 Diabetes Mellitus
- Heart Attack or Stroke within the last 6 months
- Pregnant or lactating females
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 |
|---|---|---|
| Captopril25mg Captopril | Drug | Arm A, Captopril |
| placeboplacebo | Drug | Arm A, Captopril |
Primary outcome
Change in ophthalmic artery blood flow from baseline
Time frame: 1 hour post drug, 2 hours post drug, 3 hours post drug
Eye blood flow will be measured at baseline and post drug time points (3 total)
2 secondary outcomes
Change in blood pressure from baseline
Time frame: Every 15 minutes for 3 hours
Change in renal plasma flow (RPF) from baseline
Time frame: 1 hour post drug, 2 hours post drug, 3 hours post drug
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
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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.
Norman K Hollenberg, MD, PhD principal investigator
Brigham and Women's Hospital
Ebrahim Barkoudah, M.D.,M.P.H. study director
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Captopril in people with Type 2 Diabetes Mellitus, run by Brigham and Women's Hospital 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 1 inclusion and 3 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: status not confirmed, 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ebrahim Barkoudah, M.D.,M.P.H. (617-732-6901, ebarkoudah@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ophthalmic artery blood flow from baseline (time frame: 1 hour post drug, 2 hours post drug, 3 hours post drug). 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.