HypertensionPhase 4NCT02102243
Neural Mechanism of Aldosterone-induced Insulin Resistance
A Phase 4 study testing DEFINITY® infusion, Human Recombinant Regular Insulin infusion and Dextrose infusion in people with Hypertension, run by Wanpen Vongpatanasin at 1 site in United States.
Trial summary
Patients with high aldosterone hormone have higher blood glucose than normal people. This study is being done to understand how aldosterone hormone affects the nerve activity that controls blood flow in the muscles and blood glucose. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- DEFINITY® infusion, Human Recombinant Regular Insulin infusion and Dextrose infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Dec 2025
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normotensive controls
- Stage I (140-159/90-99 mmHg) untreated subjects with essential hypertension
- Patients with PA and stage I (140-159/90-99 mmHg) hypertension
Who cannot join
- Congestive heart failure or coronary artery disease
- Blood pressure averaging > 159/99 mmHg
- Serum creatinine > 1.5 mg/dL
- Diabetes mellitus or other systemic illness
- Left ventricular hypertrophy by echocardiography or ECG
- Pregnancy
Show all 11Show fewer
- Hypersensitivity to spironolactone, chlorthalidone, amlodipine, human recombinant insulin or Definity
- Any history of substance abuse (other than tobacco)
- History of gouty arthritis
- Patients with right-to-left, bi-directional, or transient right-to-left cardiac shunts
- Hypersensitivity to perflutren, blood, blood products or albumin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Aldosterone on Sympathetic Nerve Activity and Insulin Sensitivity
Patients with high aldosterone hormone have higher blood glucose than normal people. This study is being done to understand how aldosterone hormone affects the nerve activity that controls blood flow in the muscles and blood glucose. The information may be helpful in selecting blood pressure medications which can improve not only blood pressure but also improve blood sugar.
Read the detailed description
Patients with primary aldosteronism are known to have impaired insulin sensitivity, which is improved after removal of aldosterone-producing adenoma. In patients with essential hypertension, plasma aldosterone levels have been also shown to positively correlate with indices of insulin resistance.
Mechanism underlying aldosterone-induced insulin resistance is unknown. Aldosterone has been shown to interfere with insulin signaling the vascular cells by increasing production of reactive oxygen species via activation of NADPH oxidase, resulting in decreased availability of nitric oxide (NO), the key mediator for insulin-mediated vasodilation. Treatment with mineralocorticoid receptor antagonists has been shown to improve insulin sensitivity in mice with obesity and metabolic syndrome. Aldosterone has also been shown to increase resting sympathetic vasoconstrictor activity to the peripheral circulation. However, effects of aldosterone and mineralocorticoid receptor antagonists on insulin-mediated skeletal muscle vasodilation, sympathetic activation, and vascular oxidative stress have not been assessed in humans.
The investigators will collect venous endothelial cells, and measure skeletal muscle microvascular perfusion using Octafluoropropane microbubble contrast agents, and measure sympathetic nerve activity in normotensive controls (NT), stage 1 essential hypertensive subjects (ET), and patients with primary aldosteronism (PA) during hyperinsulinemic euglycemic clamp.
- Conditions
- Hypertension
- Being tested
- DEFINITY® infusion, Human Recombinant Regular Insulin infusion, Dextrose infusion, Flow mediated vasodilation, Endothelial cell collection
- Keywords
- hypertension, blood pressure, sympathetic nerve activity, vascular oxidative stress, nitric oxide, nitric oxide synthase (eNOS), endothelium, endothelial dysfunction, endothelial cell protein expression, microvascular blood flow, flow mediated dilation, endothelial cell collection, microbubbles, Definity
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEFINITY® infusionDrug
Also called (IND# 104397)
The DEFINITY® vial contains components that upon activation yield perflutren lipid microspheres, a diagnostic drug that is intended to be used for contrast enhancement during echocardiographic procedures. The vial contains a clear, colorless, sterile, non-pyrogenic, hypertonic liquid, which upon activation with agitation, provides a homogeneous, opaque, milky white injectable suspension of perflutren lipid microspheres. The suspension of activated DEFINITY® will be infused intravenously at a rate of 0.20 to 0.27 ml/min, not to exceed a maximum dose of 2 vials per study subject per day or visit.
Human Recombinant Regular Insulin infusionDrug
Also called Humulin R, National Drug Code # 0002-8501-01
The plasma insulin concentration will be acutely raised and maintained at at a steady state by a prime-continuous insulin infusion.
Dextrose infusionDrug
Also called Dextrose 20%
The plasma glucose concentration will be held constant at 90 mg/dl by a variable glucose infusion during euglycemic hyperinsulinemic clamp
Flow mediated vasodilationProcedure or surgery
Also called FMD, Endothelial Dependent Vasodilation
Flow mediated vasodilation (FMD), which is a non-invasive assessment of endothelial function, will be performed on the brachial artery using ultrasound. After a clear picture of the artery has been obtained, the cuff on the same arm will be inflated until it is tight for five minutes. During and following this, the subject's arm will continue to be imaged to monitor maximal increase in the brachial artery diameter.
Endothelial cell collectionProcedure or surgery
We will collect endothelial cells from a superficial vein, usually in the arm. Following insertion of a peripheral intravenous (IV) catheter, we will collect cells from the inner lining of the vein using a thin, flexible J-tipped wire. The wire will be inserted through the IV into the vein and then removed, along with a sampling of endothelial cells. The cells collected will be processed and stained for several proteins involved in endothelial cell function, using immunofluorescent technique.
Microvascular perfusion assessment using DefinityProcedure or surgery
Using high-resolution ultrasound, we will measure skeletal muscle blood flow during infusion of a solution containing the octafluoropropane microbubble contrast agent, Definity. The solution will be a dilution of 1 vial of Definity to 30 cc of normal saline. The ultrasound probe will be placed over the forearm to obtain images while octafluoropropane microbubbles (Definity) are infused intravenously at the rate of 0.20 to 0.27 ml/min, not to exceed a maximum dose of 2 vials per study subject per day or visit. The microvascular perfusion assessment using Definity be performed at rest as well as during slow and fast handgrip exercises.
MicroneurographyProcedure or surgery
Also called Assessment of sympathetic nerve activity (SNA)
Sympathetic nerve activity from the peroneal nerve measured by inserting a tiny needle directly into the nerve in the leg. Investigators will localize the nerve by electrical stimulation over the skin using a blunt probe. .The recording needle will remain in position throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| Hyperinsulinemic euglycemic clamp | Experimental | We will perform following procedures:
DEFINITY® infusion Flow mediated vasodilation Endothelial cell collection Microvascular perfusion assessment using Definity Microneurography Receives: Drug: DEFINITY® infusion; Drug: Human Recombinant Regular Insulin infusion; Drug: Dextrose infusion; Procedure: Flow mediated vasodilation; Procedure: Endothelial cell collection; Procedure: Microvascular perfusion assessment using Definity; Procedure: Microneurography |
| Initial Saline Infusion | Experimental | We will perform the following procedures:
DEFINITY® infusion Human Recombinant Regular Insulin infusion Dextrose infusion Flow mediated vasodilation Endothelial cell collection Microvascular perfusion assessment using Definity Microneurography Receives: Drug: DEFINITY® infusion; Procedure: Flow mediated vasodilation; Procedure: Endothelial cell collection; Procedure: Microvascular perfusion assessment using Definity; Procedure: Microneurography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in muscle sympathetic nerve activity during hyperinsulinemic euglycemic clamp
Measured: 1 day
Secondary outcomes (5)
Change in microvascular blood flow during hyperinsulinemic euglycemic clamp.
Measured: 1 day
Change in microvascular blood flow during saline infusion.
Measured: 1 day
Change in endothelial cell protein expression after hyperinsulinemic euglycemic clamp
Measured: 1 day
Change in endothelial cell protein expression after saline infusion
Measured: 1 day
Increase in muscle sympathetic nerve activity during saline infusion
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startNov 2010
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: No longer interested in study topic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wanpen Vongpatanasin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wanpen Vongpatanasin, University of Texas Southwestern Medical Center
- Investigators
- Wanpen Vongpatanasin, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02102243
- Sponsor's protocol ID
- STU 102010-063
- Status last verified
- Mar 2023
- First submitted
- 6 Mar 2014
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Catena C, Lapenna R, Baroselli S, Nadalini E, Colussi G, Novello M, Favret G, Melis A, Cavarape A, Sechi LA. Insulin sensitivity in patients with primary aldosteronism: a follow-up study. J Clin Endocrinol Metab. 2006 Sep;91(9):3457-63. doi: 10.1210/jc.2006-0736. Epub 2006 Jul 5.
PubMed 16822818Donato AJ, Gano LB, Eskurza I, Silver AE, Gates PE, Jablonski K, Seals DR. Vascular endothelial dysfunction with aging: endothelin-1 and endothelial nitric oxide synthase. Am J Physiol Heart Circ Physiol. 2009 Jul;297(1):H425-32. doi: 10.1152/ajpheart.00689.2008. Epub 2009 May 22.
PubMed 19465546Colussi G, Catena C, Lapenna R, Nadalini E, Chiuch A, Sechi LA. Insulin resistance and hyperinsulinemia are related to plasma aldosterone levels in hypertensive patients. Diabetes Care. 2007 Sep;30(9):2349-54. doi: 10.2337/dc07-0525. Epub 2007 Jun 15.
PubMed 17575088Kontak AC, Wang Z, Arbique D, Adams-Huet B, Auchus RJ, Nesbitt SD, Victor RG, Vongpatanasin W. Reversible sympathetic overactivity in hypertensive patients with primary aldosteronism. J Clin Endocrinol Metab. 2010 Oct;95(10):4756-61. doi: 10.1210/jc.2010-0823. Epub 2010 Jul 21.
PubMed 20660053
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Aldosterone on Sympathetic Nerve Activity and Insulin Sensitivity
- ClinicalTrials.gov ID
- NCT02102243
- Acronym / sponsor ID
- STU 102010-063
- Conditions
- Hypertension
- Keywords
- hypertension, blood pressure, sympathetic nerve activity, vascular oxidative stress, nitric oxide, nitric oxide synthase (eNOS), endothelium, endothelial dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No longer interested in study topic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wanpen VongpatanasinUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 2 Apr 2014 (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.
Patients with high aldosterone hormone have higher blood glucose than normal people. This study is being done to understand how aldosterone hormone affects the nerve activity that controls blood flow in the muscles and blood glucose. The information may be helpful in selecting blood pressure medications which can improve not only blood pressure but also improve blood sugar.
Detailed description
Patients with primary aldosteronism are known to have impaired insulin sensitivity, which is improved after removal of aldosterone-producing adenoma. In patients with essential hypertension, plasma aldosterone levels have been also shown to positively correlate with indices of insulin resistance.
Mechanism underlying aldosterone-induced insulin resistance is unknown. Aldosterone has been shown to interfere with insulin signaling the vascular cells by increasing production of reactive oxygen species via activation of NADPH oxidase, resulting in decreased availability of nitric oxide (NO), the key mediator for insulin-mediated vasodilation. Treatment with mineralocorticoid receptor antagonists has been shown to improve insulin sensitivity in mice with obesity and metabolic syndrome. Aldosterone has also been shown to increase resting sympathetic vasoconstrictor activity to the peripheral circulation. However, effects of aldosterone and mineralocorticoid receptor antagonists on insulin-mediated skeletal muscle vasodilation, sympathetic activation, and vascular oxidative stress have not been assessed in humans.
The investigators will collect venous endothelial cells, and measure skeletal muscle microvascular perfusion using Octafluoropropane microbubble contrast agents, and measure sympathetic nerve activity in normotensive controls (NT), stage 1 essential hypertensive subjects (ET), and patients with primary aldosteronism (PA) during hyperinsulinemic euglycemic clamp.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperinsulinemic euglycemic clamp | Experimental | Drug: DEFINITY® infusion, Drug: Human Recombinant Regular Insulin infusion, Drug: Dextrose infusion, Procedure: Flow mediated vasodilation, Procedure: Endothelial cell collection, Procedure: Microvascular perfusion assessment using Definity, Procedure: MicroneurographyWe will perform following procedures: DEFINITY® infusion Flow mediated vasodilation Endothelial cell collection Microvascular perfusion assessment using Definity Microneurography |
| Initial Saline Infusion | Experimental | Drug: DEFINITY® infusion, Procedure: Flow mediated vasodilation, Procedure: Endothelial cell collection, Procedure: Microvascular perfusion assessment using Definity, Procedure: MicroneurographyWe will perform the following procedures: DEFINITY® infusion Human Recombinant Regular Insulin infusion Dextrose infusion Flow mediated vasodilation Endothelial cell collection Microvascular perfusion assessment using Definity Microneurography |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Normotensive controls
- Stage I (140-159/90-99 mmHg) untreated subjects with essential hypertension
- Patients with PA and stage I (140-159/90-99 mmHg) hypertension
Key exclusion criteria (11 listed)
- Congestive heart failure or coronary artery disease
- Blood pressure averaging > 159/99 mmHg
- Serum creatinine > 1.5 mg/dL
- Diabetes mellitus or other systemic illness
- Left ventricular hypertrophy by echocardiography or ECG
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 |
|---|---|---|
| DEFINITY® infusionAlso: (IND# 104397)The DEFINITY® vial contains components that upon activation yield perflutren lipid microspheres, a diagnostic drug that is intended to be used for contrast enhancement during echocardiographic procedures. The vial contains a clear, colorless, sterile, non-pyrogenic, hypertonic liquid, which upon activation with agitation, provides a homogeneous, opaque, milky white injectable suspension of perflutren lipid microspheres. The suspension of activated DEFINITY® will be infused intravenously at a rate of 0.20 to 0.27 ml/min, not to exceed a maximum dose of 2 vials per study subject per day or visit. | Drug | Hyperinsulinemic euglycemic clamp, Initial Saline Infusion |
| Human Recombinant Regular Insulin infusionAlso: Humulin R, National Drug Code # 0002-8501-01The plasma insulin concentration will be acutely raised and maintained at at a steady state by a prime-continuous insulin infusion. | Drug | Hyperinsulinemic euglycemic clamp |
| Dextrose infusionAlso: Dextrose 20%The plasma glucose concentration will be held constant at 90 mg/dl by a variable glucose infusion during euglycemic hyperinsulinemic clamp | Drug | Hyperinsulinemic euglycemic clamp |
| Flow mediated vasodilationAlso: FMD, Endothelial Dependent VasodilationFlow mediated vasodilation (FMD), which is a non-invasive assessment of endothelial function, will be performed on the brachial artery using ultrasound. After a clear picture of the artery has been obtained, the cuff on the same arm will be inflated until it is tight for five minutes. During and following this, the subject's arm will continue to be imaged to monitor maximal increase in the brachial artery diameter. | Procedure or surgery | Hyperinsulinemic euglycemic clamp, Initial Saline Infusion |
| Endothelial cell collectionWe will collect endothelial cells from a superficial vein, usually in the arm. Following insertion of a peripheral intravenous (IV) catheter, we will collect cells from the inner lining of the vein using a thin, flexible J-tipped wire. The wire will be inserted through the IV into the vein and then removed, along with a sampling of endothelial cells. The cells collected will be processed and stained for several proteins involved in endothelial cell function, using immunofluorescent technique. | Procedure or surgery | Hyperinsulinemic euglycemic clamp, Initial Saline Infusion |
| Microvascular perfusion assessment using DefinityUsing high-resolution ultrasound, we will measure skeletal muscle blood flow during infusion of a solution containing the octafluoropropane microbubble contrast agent, Definity. The solution will be a dilution of 1 vial of Definity to 30 cc of normal saline. The ultrasound probe will be placed over the forearm to obtain images while octafluoropropane microbubbles (Definity) are infused intravenously at the rate of 0.20 to 0.27 ml/min, not to exceed a maximum dose of 2 vials per study subject per day or visit. The microvascular perfusion assessment using Definity be performed at rest as well as during slow and fast handgrip exercises. | Procedure or surgery | Hyperinsulinemic euglycemic clamp, Initial Saline Infusion |
| MicroneurographyAlso: Assessment of sympathetic nerve activity (SNA)Sympathetic nerve activity from the peroneal nerve measured by inserting a tiny needle directly into the nerve in the leg. Investigators will localize the nerve by electrical stimulation over the skin using a blunt probe. .The recording needle will remain in position throughout the study. | Procedure or surgery | Hyperinsulinemic euglycemic clamp, Initial Saline Infusion |
Primary outcome
Increase in muscle sympathetic nerve activity during hyperinsulinemic euglycemic clamp
Time frame: 1 day
5 secondary outcomes
Change in microvascular blood flow during hyperinsulinemic euglycemic clamp.
Time frame: 1 day
Change in microvascular blood flow during saline infusion.
Time frame: 1 day
Change in endothelial cell protein expression after hyperinsulinemic euglycemic clamp
Time frame: 1 day
Change in endothelial cell protein expression after saline infusion
Time frame: 1 day
Increase in muscle sympathetic nerve activity during saline infusion
Time frame: 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Background: PubMed 16822818Catena C, Lapenna R, Baroselli S, Nadalini E, Colussi G, Novello M, Favret G, Melis A, Cavarape A, Sechi LA. Insulin sensitivity in patients with primary aldosteronism: a follow-up study. J Clin Endocrinol Metab. 2006 Sep;91(9):3457-63. doi: 10.1210/jc.2006-0736. Epub 2006 Jul 5.
- Background: PubMed 19465546Donato AJ, Gano LB, Eskurza I, Silver AE, Gates PE, Jablonski K, Seals DR. Vascular endothelial dysfunction with aging: endothelin-1 and endothelial nitric oxide synthase. Am J Physiol Heart Circ Physiol. 2009 Jul;297(1):H425-32. doi: 10.1152/ajpheart.00689.2008. Epub 2009 May 22.
- Background: PubMed 17575088Colussi G, Catena C, Lapenna R, Nadalini E, Chiuch A, Sechi LA. Insulin resistance and hyperinsulinemia are related to plasma aldosterone levels in hypertensive patients. Diabetes Care. 2007 Sep;30(9):2349-54. doi: 10.2337/dc07-0525. Epub 2007 Jun 15.
- Background: PubMed 20660053Kontak AC, Wang Z, Arbique D, Adams-Huet B, Auchus RJ, Nesbitt SD, Victor RG, Vongpatanasin W. Reversible sympathetic overactivity in hypertensive patients with primary aldosteronism. J Clin Endocrinol Metab. 2010 Oct;95(10):4756-61. doi: 10.1210/jc.2010-0823. Epub 2010 Jul 21.
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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.
Wanpen Vongpatanasin, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DEFINITY® infusion, Human Recombinant Regular Insulin infusion and Dextrose infusion in people with Hypertension, run by Wanpen Vongpatanasin 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 3 inclusion and 11 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: withdrawn, as of the sponsor's last update on 15 Mar 2023. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Increase in muscle sympathetic nerve activity during hyperinsulinemic euglycemic clamp (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02102243, which also lists 4 linked publications.
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 15 Mar 2023.