Diabetes MellitusNCT01511042
Vascular Dysfunction in Diabetes: Genes and Hormones
An observational study of Diabetes Mellitus, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Para-aminohippuric Acid, Angiotensin II and Norepinephrine
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1999to Jun 2020
- How long will I take part?
- 20 Years
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Type II Diabetes Mellitus * Age between 18-65 years * BMI < 40 * In overall good health
Who may be able to join
- Type II Diabetes Mellitus
- Age between 18-65 years
- BMI < 40
- In overall good health
Who cannot join
- History of coronary atherosclerotic disease, MI, CVA, or significant peripheral vascular disease
- BMI > 40
- Subjects with diastolic blood pressures greater than 100 mm Hg while on anti-hypertensive medications, or systolic blood pressures greater than 160 mm Hg while on anti-hypertensive medications will be excluded.
- Current alcohol or drug abuse
- Subjects taking other medications (except thyroid supplements, oral hyperglycemic agents and insulin) will be excluded
- Subjects who are on medications that cannot be discontinued such as anti-depressants, anti-seizure medications, etc that may interfere with salt and water handling will not be studied.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital- 221 Longwood Avenue
Boston, Massachusetts, 02115
About this study
Official title: Non-Modulation Phenotype and Vascular Dysfunction in Diabetes Mellitus
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.
Read more
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 days to report your blood pressure readings. Less than 20% of patients with hypertension have any significant increase in their blood pressure during this short time off therapy. After you have been off your medication for nine days the dieticians will give you low salt meals to eat at home for six days. On the sixth day of the low salt diet, you will be asked to begin a 24-hour urine collection. You will also be required to come to the Ambulatory Clinical Center (221 Longwood Ave.) for a one-hour test. You will return that evening to the inpatient Clinical Research Center where you will be admitted for your first study that will occur the next morning. On the morning of your low salt study you will have three naturally occurring hormones administered and blood samples drawn from an intravenous needle. The investigators will also take ultrasound pictures of your heart to see how salt and hormones affect the way the heart functions. These tests will last approximately five hours and you will be discharged around 12:00 p.m. The dieticians will then give you your meals for the next week to take home. Each of these meals will have a high salt content. After six days of your high salt diet, on the morning of your second admission to the hospital, you will be asked to begin a final 24-hour urine collection. The same study that was done for the low salt study will be repeated for the high salt study. You will be discharged around 3:00 p.m. This study will determine if you are salt-sensitive. A high salt diet has been found to lead to higher blood pressure and weight gain. In addition, the investigators hope to learn more about the hormones that regulate your blood pressure and the genes responsible for regulating those hormones.
You will be placed back on your initial blood pressure medication (if you are on any) and returned to your regular physician for care. The investigators will provide clinically relevant information to you and your physician.
- Conditions
- Diabetes Mellitus
- Being tested
- Para-aminohippuric Acid, Angiotensin II, Norepinephrine
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Para-aminohippuric AcidDrug
Also called PAH
Aminohippurate sodium is an agent to measure effective renal plasma flow (ERPF). It is the sodium salt of para-aminohippuric acid, commonly abbreviated "PAH".
Angiotensin IIDrug
Also called AngII, AII
Angiotensin II (Ang II) is a naturally occurring hormone whose primary purpose is to regulate the body's internal volume. It accomplishes this task by influencing the function of a variety of organs and tissues. It increases aldosterone secretion from the adrenal gland. It causes blood vessels to contract, particularly renal blood vessels, and it modifies the way the heart works.
NorepinephrineDrug
Also called NE
A hormone that is normally present in your body, which regulates your blood pressure.
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Intermediate Phenotypes in Subjects with Diabetes Mellitus versus Hypertension
The frequency of salt sensitive blood pressure
Measured: 10 Years
Secondary outcomes (2)
Frequency of polymorphic variants in AGT gene in Hypertensives versus diabetics
The frequency of polymorphisms in the angiotensinogen (AGT), ACE and ALDO synthase and ALAP genes in non-modulating hypertension subset.
Measured: 10 Years
Frequency of salt sensitive subtype in Diabetics versus hypertensives
Frequency of non-modulating phenotype and low renin phenotype in the salt sensitive subjects.subjects.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2012 (estimated)
- Study startDec 1999
- Primary completionJan 2020
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gordon H. Williams, MD, Brigham and Women's Hospital
- Investigators
- Gordon H Williams, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01511042
- Sponsor's protocol ID
- 1999P001983
- Status last verified
- Nov 2022
- First submitted
- 19 Jul 2011
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Modulation Phenotype and Vascular Dysfunction in Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01511042
- Acronym / sponsor ID
- 1999P001983
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Dec 1999 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 18 Jan 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 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 days to report your blood pressure readings. Less than 20% of patients with hypertension have any significant increase in their blood pressure during this short time off therapy. After you have been off your medication for nine days the dieticians will give you low salt meals to eat at home for six days. On the sixth day of the low salt diet, you will be asked to begin a 24-hour urine collection. You will also be required to come to the Ambulatory Clinical Center (221 Longwood Ave.) for a one-hour test. You will return that evening to the inpatient Clinical Research Center where you will be admitted for your first study that will occur the next morning. On the morning of your low salt study you will have three naturally occurring hormones administered and blood samples drawn from an intravenous needle. The investigators will also take ultrasound pictures of your heart to see how salt and hormones affect the way the heart functions. These tests will last approximately five hours and you will be discharged around 12:00 p.m. The dieticians will then give you your meals for the next week to take home. Each of these meals will have a high salt content. After six days of your high salt diet, on the morning of your second admission to the hospital, you will be asked to begin a final 24-hour urine collection. The same study that was done for the low salt study will be repeated for the high salt study. You will be discharged around 3:00 p.m. This study will determine if you are salt-sensitive. A high salt diet has been found to lead to higher blood pressure and weight gain. In addition, the investigators hope to learn more about the hormones that regulate your blood pressure and the genes responsible for regulating those hormones.
You will be placed back on your initial blood pressure medication (if you are on any) and returned to your regular physician for care. The investigators will provide clinically relevant information to you and your physician.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 20 Years
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Type II Diabetes Mellitus * Age between 18-65 years * BMI < 40 * In overall good health
Key inclusion criteria (4 listed)
- Type II Diabetes Mellitus
- Age between 18-65 years
- BMI < 40
- In overall good health
Key exclusion criteria (6 listed)
- History of coronary atherosclerotic disease, MI, CVA, or significant peripheral vascular disease
- BMI > 40
- Subjects with diastolic blood pressures greater than 100 mm Hg while on anti-hypertensive medications, or systolic blood pressures greater than 160 mm Hg while on anti-hypertensive medications will be excluded.
- Current alcohol or drug abuse
- Subjects taking other medications (except thyroid supplements, oral hyperglycemic agents and insulin) will be excluded
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 |
|---|---|---|
| Para-aminohippuric AcidAlso: PAHAminohippurate sodium is an agent to measure effective renal plasma flow (ERPF). It is the sodium salt of para-aminohippuric acid, commonly abbreviated "PAH". | Drug | – |
| Angiotensin IIAlso: AngII, AIIAngiotensin II (Ang II) is a naturally occurring hormone whose primary purpose is to regulate the body's internal volume. It accomplishes this task by influencing the function of a variety of organs and tissues. It increases aldosterone secretion from the adrenal gland. It causes blood vessels to contract, particularly renal blood vessels, and it modifies the way the heart works. | Drug | – |
| NorepinephrineAlso: NEA hormone that is normally present in your body, which regulates your blood pressure. | Drug | – |
Primary outcome
Frequency of Intermediate Phenotypes in Subjects with Diabetes Mellitus versus Hypertension
Time frame: 10 Years
The frequency of salt sensitive blood pressure
2 secondary outcomes
Frequency of polymorphic variants in AGT gene in Hypertensives versus diabetics
Time frame: 10 Years
Frequency of salt sensitive subtype in Diabetics versus hypertensives
Time frame: 10 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
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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.
Gordon H Williams, MD principal investigator
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?
An observational study of 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 4 inclusion and 6 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 9 Nov 2022. 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.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Frequency of Intermediate Phenotypes in Subjects with Diabetes Mellitus versus Hypertension (time frame: 10 Years). 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 9 Nov 2022; AzTrials last refreshed its copy on 3 Nov 2026.