Vascular StiffnessEarly Phase 1EJB050NCT03520569

Effect of Hyperglycemia on Microvascular Perfusion in Healthy Adults

A Early Phase 1 study testing Octreotide, Insulin and Dextrose 20% solution in people with Vascular Stiffness and Insulin Sensitivity, run by University of Virginia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The investigators are studying the effects of Hyperglycemia on vascular function and insulin sensitivity on healthy adults Read more about this study

Who is it for?: Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for: Vascular Stiffness, Insulin Sensitivity
What is being tested?: Octreotide, Insulin and Dextrose 20% solution
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: 4 Feb 2019to 1 Apr 2021
Phase: Early 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 35 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy with no chronic illness
Age 18-35
Normal BMI (18-25)
Normal screening labs or no clinically significant values

Who cannot join

First degree relative with Type 2 Diabetes
Smoking presently or in the past 6 months
Medications that affect the vasculature
Overweight or other indications of insulin resistance
Elevated LDL cholesterol > 160
Elevated BP > 140/90

Show all 11Show fewer

History of congestive heart failure, ischemic heart disease, severe pulmonary disease, liver or kidney disease, bleeding disorders
Any vascular disease such as myocardial infarction, stroke, peripheral vascular disease
Presence of an intracardiac or intrapulmonary shunt (we will screen for this by auscultation during the physical exam by PI).
Pregnant or breastfeeding.
Known hypersensitivity to perflutren (contained in Definity)

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Virginia
Charlottesville, Virginia, 22908

Other trials in United States

About this study

The investigators are studying the effects of Hyperglycemia on vascular function and insulin sensitivity on healthy adults

Read the detailed description

The investigators will study 22 healthy subjects (18-35 yrs) four times as follows:

Saline + Octreotide + euglycemia;
Octreotide + hyperglycemia;
Octreotide + hyperglycemia + insulin clamp and
Octreotide + Euglycemia + insulin clamp.

The sequence of admissions will be assigned randomly. The investigators will assess function in conduit (pulse wave velocity-PWV, augmentation index-AI and flow-mediated dilation-FMD), resistance (post-ischemic flow velocity-PIFV) and heart and skeletal muscle microvascular (contrast enhanced ultrasound-CEU) vessels.

This work will:

identify whether vascular stiffness and indices of NO action are impaired throughout the arterial tree with hyperglycemia.

Conditions: Vascular Stiffness, Insulin Sensitivity
Being tested: Octreotide, Insulin, Dextrose 20% solution
Medical subject headings: Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OctreotideDrug
we are using it to block insulin secretion from the pancreas
InsulinDrug
we are using to replace basal insulin and in two protocols to raise insulin concentrations during the insulin clamp
Dextrose 20% solutionDrug
We are using dextrose to maintain glycemia level

Study groups in NCT03520569
Study group	Role	What they receive
Octreotide- Euglycemia	Active comparator	octreotide is 30 ng/kg/min x 240 min insulin 0.15mU/kg/min x 240 min Dextrose 20% at variable rate to maintain euglycemia for 240 min Receives: Drug: Octreotide; Drug: Insulin; Drug: Dextrose 20% solution
Octreotide - Euglycemia- insulin clamp	Active comparator	octreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 210 min insulin 1.0mU/kg/min x 120 min Dextrose 20% at variable rate to maintain euglycemia for 330 min Receives: Drug: Octreotide; Drug: Insulin; Drug: Dextrose 20% solution
Octreotide- hyperglycemia	Active comparator	octreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 330 min Dextrose 20% at variable rate to maintain euglycemia for 90 min Dextrose 20% at variable rate to maintain hyperglycemia for 240 min Receives: Drug: Octreotide; Drug: Insulin; Drug: Dextrose 20% solution
Octreotide- hyperglycemia - insulin clamp	Active comparator	octreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 210 min insulin 1.0mU/kg/min x 120 min Dextrose 20% at variable rate to maintain euglycemia for 90 min Dextrose 20% at variable rate to maintain hyperglycemia for 240 min Receives: Drug: Octreotide; Drug: Insulin; Drug: Dextrose 20% solution

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Flow Mediated Dilation (FMD) Between Baseline and After 2 Hour Insulin Clamp
Flow mediated dilation measures the change in brachial diameter in response to 5 minutes of ischemia using B-mode ultrasound. It provides an index of nitric oxide generation by the endothelium .
Measured: baseline and after 2 hour insulin clamp

Secondary outcomes (2)

Change in Augmentation Index Between Baseline and After 2 Hour Insulin Clamp
The augmentation index (AIx) measured at the radial artery is a measure of systemic arterial stiffness, and is defined as the ratio of augmentation (Δ P) to central pulse pressure and expressed as percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. Higher percentages indicate increased arterial stiffness.
Measured: baseline and after 2 hour insulin clamp
Change in Pulse Wave Velocity (PWV) Between Baseline and After 2 Hour Insulin Clamp
The time required for a blood pressure wave to travel from the carotid to the femoral artery was measured in meter/sec. This is a measurement of central artery stiffness. Higher numbers indicate stiffer vessels
Measured: baseline and after 2 hour insulin clamp

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Feb 20191 Apr 2021

First posted9 May 2018
Study start4 Feb 2019
Primary completion1 Apr 2021
Study completion1 Apr 2021

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.
Publications (31)Papers the sponsor has linked to this study.
Other trials for Vascular StiffnessStudies of the same condition, open and under way.
More trials run by University of VirginiaThe 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: Early Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Model description: Each subject is studied 4 times in a randomized sequential order
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03520569
Sponsor's protocol ID: 19948
Other IDs: T32DK007646
Acronym: EJB050
Status last verified: Apr 2022
First submitted: 8 Mar 2018
Last updated: 13 May 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Deedwania P, Kosiborod M, Barrett E, Ceriello A, Isley W, Mazzone T, Raskin P. Hyperglycemia and acute coronary syndrome: a scientific statement from the American Heart Association Diabetes Committee of the Council on Nutrition, Physical Activity, and Metabolism. Anesthesiology. 2008 Jul;109(1):14-24. doi: 10.1097/ALN.0b013e31817dced3.
PubMed 18580168
Brownlee M. Biochemistry and molecular cell biology of diabetic complications. Nature. 2001 Dec 13;414(6865):813-20. doi: 10.1038/414813a.
PubMed 11742414
Giacco F, Brownlee M. Oxidative stress and diabetic complications. Circ Res. 2010 Oct 29;107(9):1058-70. doi: 10.1161/CIRCRESAHA.110.223545.
PubMed 21030723
Brouwers O, Niessen PM, Haenen G, Miyata T, Brownlee M, Stehouwer CD, De Mey JG, Schalkwijk CG. Hyperglycaemia-induced impairment of endothelium-dependent vasorelaxation in rat mesenteric arteries is mediated by intracellular methylglyoxal levels in a pathway dependent on oxidative stress. Diabetologia. 2010 May;53(5):989-1000. doi: 10.1007/s00125-010-1677-0. Epub 2010 Feb 26.
PubMed 20186387
Ceriello A, Taboga C, Tonutti L, Quagliaro L, Piconi L, Bais B, Da Ros R, Motz E. Evidence for an independent and cumulative effect of postprandial hypertriglyceridemia and hyperglycemia on endothelial dysfunction and oxidative stress generation: effects of short- and long-term simvastatin treatment. Circulation. 2002 Sep 3;106(10):1211-8. doi: 10.1161/01.cir.0000027569.76671.a8.
PubMed 12208795
Suzuki K, Watanabe K, Futami-Suda S, Yano H, Motoyama M, Matsumura N, Igari Y, Suzuki T, Nakano H, Oba K. The effects of postprandial glucose and insulin levels on postprandial endothelial function in subjects with normal glucose tolerance. Cardiovasc Diabetol. 2012 Aug 14;11:98. doi: 10.1186/1475-2840-11-98.
PubMed 22891922
Ceriello A, Novials A, Ortega E, Canivell S, La Sala L, Pujadas G, Esposito K, Giugliano D, Genovese S. Glucagon-like peptide 1 reduces endothelial dysfunction, inflammation, and oxidative stress induced by both hyperglycemia and hypoglycemia in type 1 diabetes. Diabetes Care. 2013 Aug;36(8):2346-50. doi: 10.2337/dc12-2469. Epub 2013 Apr 5.
PubMed 23564922
Perkins JM, Joy NG, Tate DB, Davis SN. Acute effects of hyperinsulinemia and hyperglycemia on vascular inflammatory biomarkers and endothelial function in overweight and obese humans. Am J Physiol Endocrinol Metab. 2015 Jul 15;309(2):E168-76. doi: 10.1152/ajpendo.00064.2015. Epub 2015 May 26.
PubMed 26015434
Giugliano D, Marfella R, Coppola L, Verrazzo G, Acampora R, Giunta R, Nappo F, Lucarelli C, D'Onofrio F. Vascular effects of acute hyperglycemia in humans are reversed by L-arginine. Evidence for reduced availability of nitric oxide during hyperglycemia. Circulation. 1997 Apr 1;95(7):1783-90. doi: 10.1161/01.cir.95.7.1783.
PubMed 9107164
Cuypers MH, Kasanardjo JS, Polak BC. Retinal blood flow changes in diabetic retinopathy measured with the Heidelberg scanning laser Doppler flowmeter. Graefes Arch Clin Exp Ophthalmol. 2000 Dec;238(12):935-41. doi: 10.1007/s004170000207.
PubMed 11196354
Horova E, Mazoch J, Hiigertova J, Kvasnicka J, Skrha J, Soupal J, Prazny M. Acute hyperglycemia does not impair microvascular reactivity and endothelial function during hyperinsulinemic isoglycemic and hyperglycemic clamp in type 1 diabetic patients. Exp Diabetes Res. 2012;2012:851487. doi: 10.1155/2012/851487. Epub 2012 Jan 4.
PubMed 22262970
Burgansky-Eliash Z, Barak A, Barash H, Nelson DA, Pupko O, Lowenstein A, Grinvald A, Rubinstein A. Increased retinal blood flow velocity in patients with early diabetes mellitus. Retina. 2012 Jan;32(1):112-9. doi: 10.1097/IAE.0b013e31821ba2c4.
PubMed 21878846
Rattigan S, Clark MG, Barrett EJ. Hemodynamic actions of insulin in rat skeletal muscle: evidence for capillary recruitment. Diabetes. 1997 Sep;46(9):1381-8. doi: 10.2337/diab.46.9.1381.
PubMed 9287035
Chai W, Zhang X, Barrett EJ, Liu Z. Glucagon-like peptide 1 recruits muscle microvasculature and improves insulin's metabolic action in the presence of insulin resistance. Diabetes. 2014 Aug;63(8):2788-99. doi: 10.2337/db13-1597. Epub 2014 Mar 21.
PubMed 24658303
Vincent MA, Dawson D, Clark AD, Lindner JR, Rattigan S, Clark MG, Barrett EJ. Skeletal muscle microvascular recruitment by physiological hyperinsulinemia precedes increases in total blood flow. Diabetes. 2002 Jan;51(1):42-8. doi: 10.2337/diabetes.51.1.42.
PubMed 11756321

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Vascular Stiffness trials

Study at a glance

From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Hyperglycemia on Microvascular Perfusion in Healthy Adults
ClinicalTrials.gov ID: NCT03520569
Acronym / sponsor ID: EJB050 / 19948
Conditions: Vascular Stiffness, Insulin Sensitivity
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: University of VirginiaUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 4 Feb 2019 (actual)
Primary completion: 1 Apr 2021 (actual)
Study completion: 1 Apr 2021 (actual)
First posted: 9 May 2018 (actual)
Results: Posted 13 May 2022

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 studying the effects of Hyperglycemia on vascular function and insulin sensitivity on healthy adults

Detailed description

The investigators will study 22 healthy subjects (18-35 yrs) four times as follows:

Saline + Octreotide + euglycemia;
Octreotide + hyperglycemia;
Octreotide + hyperglycemia + insulin clamp and
Octreotide + Euglycemia + insulin clamp.

This work will:

identify whether vascular stiffness and indices of NO action are impaired throughout the arterial tree with hyperglycemia.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4
Model description: Each subject is studied 4 times in a randomized sequential order

Arm	Type	Receives
Octreotide- Euglycemia	Active comparator	Drug: Octreotide, Drug: Insulin, Drug: Dextrose 20% solutionoctreotide is 30 ng/kg/min x 240 min insulin 0.15mU/kg/min x 240 min Dextrose 20% at variable rate to maintain euglycemia for 240 min
Octreotide - Euglycemia- insulin clamp	Active comparator	Drug: Octreotide, Drug: Insulin, Drug: Dextrose 20% solutionoctreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 210 min insulin 1.0mU/kg/min x 120 min Dextrose 20% at variable rate to maintain euglycemia for 330 min
Octreotide- hyperglycemia	Active comparator	Drug: Octreotide, Drug: Insulin, Drug: Dextrose 20% solutionoctreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 330 min Dextrose 20% at variable rate to maintain euglycemia for 90 min Dextrose 20% at variable rate to maintain hyperglycemia for 240 min
Octreotide- hyperglycemia - insulin clamp	Active comparator	Drug: Octreotide, Drug: Insulin, Drug: Dextrose 20% solutionoctreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 210 min insulin 1.0mU/kg/min x 120 min Dextrose 20% at variable rate to maintain euglycemia for 90 min Dextrose 20% at variable rate to maintain hyperglycemia for 240 min

Who may qualify

Ages: 18 to 35 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy with no chronic illness
Age 18-35
Normal BMI (18-25)
Normal screening labs or no clinically significant values

Key exclusion criteria (11 listed)

First degree relative with Type 2 Diabetes
Smoking presently or in the past 6 months
Medications that affect the vasculature
Overweight or other indications of insulin resistance
Elevated LDL cholesterol > 160

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
Octreotidewe are using it to block insulin secretion from the pancreas	Drug	Octreotide - Euglycemia- insulin clamp, Octreotide- Euglycemia, Octreotide- hyperglycemia, Octreotide- hyperglycemia - insulin clamp
Insulinwe are using to replace basal insulin and in two protocols to raise insulin concentrations during the insulin clamp	Drug	Octreotide - Euglycemia- insulin clamp, Octreotide- Euglycemia, Octreotide- hyperglycemia, Octreotide- hyperglycemia - insulin clamp
Dextrose 20% solutionWe are using dextrose to maintain glycemia level	Drug	Octreotide - Euglycemia- insulin clamp, Octreotide- Euglycemia, Octreotide- hyperglycemia, Octreotide- hyperglycemia - insulin clamp

Primary outcome

Change in Flow Mediated Dilation (FMD) Between Baseline and After 2 Hour Insulin Clamp
Time frame: baseline and after 2 hour insulin clamp
Flow mediated dilation measures the change in brachial diameter in response to 5 minutes of ischemia using B-mode ultrasound. It provides an index of nitric oxide generation by the endothelium .

2 secondary outcomes

Change in Augmentation Index Between Baseline and After 2 Hour Insulin Clamp
Time frame: baseline and after 2 hour insulin clamp
Change in Pulse Wave Velocity (PWV) Between Baseline and After 2 Hour Insulin Clamp
Time frame: baseline and after 2 hour insulin clamp

Results and safety

Results posted to the registry on 13 May 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	15	14

Primary outcome: Change in Flow Mediated Dilation (FMD) Between Baseline and After 2 Hour Insulin Clamp

Time frame: baseline and after 2 hour insulin clamp. Mean (Standard Deviation). Unit: % change

Measure	Octreotide- Euglycemia n = 13	Octreotide - Euglycemia- Insulin Clamp n = 14	Octreotide- Hyperglycemia n = 10	Octreotide- Hyperglycemia - Insulin Clamp n = 12
Value	11.8 (4.4)	11.8 (4)	8.9 (4.3)	8.95 (4.5)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 20 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Octreotide- Euglycemia	0 of 13 (0%)	0 of 13 (0%)	0 of 13
Octreotide - Euglycemia- Insulin Clamp	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Octreotide- Hyperglycemia	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Octreotide- Hyperglycemia - Insulin Clamp	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 18580168Deedwania P, Kosiborod M, Barrett E, Ceriello A, Isley W, Mazzone T, Raskin P. Hyperglycemia and acute coronary syndrome: a scientific statement from the American Heart Association Diabetes Committee of the Council on Nutrition, Physical Activity, and Metabolism. Anesthesiology. 2008 Jul;109(1):14-24. doi: 10.1097/ALN.0b013e31817dced3.
Background: PubMed 11742414Brownlee M. Biochemistry and molecular cell biology of diabetic complications. Nature. 2001 Dec 13;414(6865):813-20. doi: 10.1038/414813a.
Background: PubMed 21030723Giacco F, Brownlee M. Oxidative stress and diabetic complications. Circ Res. 2010 Oct 29;107(9):1058-70. doi: 10.1161/CIRCRESAHA.110.223545.
Background: PubMed 20186387Brouwers O, Niessen PM, Haenen G, Miyata T, Brownlee M, Stehouwer CD, De Mey JG, Schalkwijk CG. Hyperglycaemia-induced impairment of endothelium-dependent vasorelaxation in rat mesenteric arteries is mediated by intracellular methylglyoxal levels in a pathway dependent on oxidative stress. Diabetologia. 2010 May;53(5):989-1000. doi: 10.1007/s00125-010-1677-0. Epub 2010 Feb 26.
Background: PubMed 12208795Ceriello A, Taboga C, Tonutti L, Quagliaro L, Piconi L, Bais B, Da Ros R, Motz E. Evidence for an independent and cumulative effect of postprandial hypertriglyceridemia and hyperglycemia on endothelial dysfunction and oxidative stress generation: effects of short- and long-term simvastatin treatment. Circulation. 2002 Sep 3;106(10):1211-8. doi: 10.1161/01.cir.0000027569.76671.a8.
Background: PubMed 22891922Suzuki K, Watanabe K, Futami-Suda S, Yano H, Motoyama M, Matsumura N, Igari Y, Suzuki T, Nakano H, Oba K. The effects of postprandial glucose and insulin levels on postprandial endothelial function in subjects with normal glucose tolerance. Cardiovasc Diabetol. 2012 Aug 14;11:98. doi: 10.1186/1475-2840-11-98.
Background: PubMed 23564922Ceriello A, Novials A, Ortega E, Canivell S, La Sala L, Pujadas G, Esposito K, Giugliano D, Genovese S. Glucagon-like peptide 1 reduces endothelial dysfunction, inflammation, and oxidative stress induced by both hyperglycemia and hypoglycemia in type 1 diabetes. Diabetes Care. 2013 Aug;36(8):2346-50. doi: 10.2337/dc12-2469. Epub 2013 Apr 5.
Background: PubMed 26015434Perkins JM, Joy NG, Tate DB, Davis SN. Acute effects of hyperinsulinemia and hyperglycemia on vascular inflammatory biomarkers and endothelial function in overweight and obese humans. Am J Physiol Endocrinol Metab. 2015 Jul 15;309(2):E168-76. doi: 10.1152/ajpendo.00064.2015. Epub 2015 May 26.
Background: PubMed 9107164Giugliano D, Marfella R, Coppola L, Verrazzo G, Acampora R, Giunta R, Nappo F, Lucarelli C, D'Onofrio F. Vascular effects of acute hyperglycemia in humans are reversed by L-arginine. Evidence for reduced availability of nitric oxide during hyperglycemia. Circulation. 1997 Apr 1;95(7):1783-90. doi: 10.1161/01.cir.95.7.1783.
Background: PubMed 11196354Cuypers MH, Kasanardjo JS, Polak BC. Retinal blood flow changes in diabetic retinopathy measured with the Heidelberg scanning laser Doppler flowmeter. Graefes Arch Clin Exp Ophthalmol. 2000 Dec;238(12):935-41. doi: 10.1007/s004170000207.
Background: PubMed 22262970Horova E, Mazoch J, Hiigertova J, Kvasnicka J, Skrha J, Soupal J, Prazny M. Acute hyperglycemia does not impair microvascular reactivity and endothelial function during hyperinsulinemic isoglycemic and hyperglycemic clamp in type 1 diabetic patients. Exp Diabetes Res. 2012;2012:851487. doi: 10.1155/2012/851487. Epub 2012 Jan 4.
Background: PubMed 21878846Burgansky-Eliash Z, Barak A, Barash H, Nelson DA, Pupko O, Lowenstein A, Grinvald A, Rubinstein A. Increased retinal blood flow velocity in patients with early diabetes mellitus. Retina. 2012 Jan;32(1):112-9. doi: 10.1097/IAE.0b013e31821ba2c4.
Individual participant dataSharing planned: No

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Octreotide, Insulin and Dextrose 20% solution in people with Vascular Stiffness and Insulin Sensitivity, run by University of Virginia 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 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: finished, as of the sponsor's last update on 13 May 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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 13 May 2022). 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?

Change in Flow Mediated Dilation (FMD) Between Baseline and After 2 Hour Insulin Clamp (time frame: baseline and after 2 hour insulin clamp). 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 NCT03520569, which also lists 31 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 13 May 2022.