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NCT01511042 · ClinicalTrials.gov registry record
Vascular Dysfunction in Diabetes: Genes and Hormones
A clinical trial, sponsored by Brigham and Women's Hospital.
- Terminated
- Registry status
- 100
- Enrollment target
NCT01511042: Clinical Trial study, sponsored by Brigham and Women's Hospital.
NCT01511042 is a clinical trial that was terminated before completion, run by Brigham and Women's Hospital. The registered enrollment target is 100 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01511042 was terminated before completion, sponsored by Brigham and Women's Hospital.
- TERMINATED
- Registry status
- 100 participants
- Enrollment target
Study Summary
The investigators are very excited that the National Institutes of Health are sponsoring us to investigate why patients with diabetes are more likely to develop high blood pressure, atherosclerosis (hardening of the arteries), and heart disease. There are two parts of our research program. The first part is a screening visit. At this visit you will be given a brief physical exam and will be asked questions concerning your medical history. During the same visit you will have your blood drawn for routine screening and to prepare DNA for genetic testing. You will also be asked to collect a urine sample for routine screening. If the doctor finds that you are a healthy candidate you will be invited to participate in the second part of the study. During Phase II the investigators will perform physiologic tests after you are placed on a low salt diet and again after you are placed on a high salt diet. All of the food that you will eat during the two diets will be provided to you by the hospital. If you are on blood pressure medication, it may be necessary to discontinue taking your present medication for up to three months before beginning the study. Patients discontinuing their current blood pressure medication may be placed on a different blood pressure medication during this washout period if necessary to maintain blood pressure at pre-study levels. The investigators will take you off all medications, except cholesterol medications two weeks prior to your scheduled in-patient study. However, if you are currently on medication to control your diabetes you will remain on this throughout the entire study. Once your blood pressure medications are discontinued, you will be closely monitored to make sure you do not encounter any difficulty. If you do not own a home blood pressure monitor, the investigators will provide one for to use during the study so that you can keep a daily record of your blood pressure readings. The investigators will ask you to call us every three da
Primary Outcome
The frequency of salt sensitive blood pressure
Interventions
- DRUG Norepinephrine
- DRUG Angiotensin II
- DRUG Para-aminohippuric Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 1999-12 |
| Est. Completion | 2020-06 |
Why NCT01511042 stopped before completion
NCT01511042 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 3 interventions - of which Norepinephrine is the first listed.
NCT01511042 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01511042 about?
NCT01511042 is a clinical study titled "Vascular Dysfunction in Diabetes: Genes and Hormones". The investigators are very excited that the National Institutes of Health are sponsoring us to investigate why patients with diabetes are more likely to develop high blood pressure, atherosclerosis (hardening of the arteries), and heart disease. There are two parts of our research program. The first...
What is the current status of trial NCT01511042?
This trial is currently terminated. The enrollment target is 100 participants. The study started on 1999-12. Estimated completion is 2020-06.
What interventions are being tested in trial NCT01511042?
The interventions under investigation include: Norepinephrine (DRUG), Angiotensin II (DRUG), Para-aminohippuric Acid (DRUG).
Who is sponsoring clinical trial NCT01511042?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
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