Type 1 DiabetesEarly Phase 1KML001NCT04133922
Effect of GLP-1 on Microvascular Insulin Responses in Type 1 Diabetes
A Early Phase 1 study testing GLP-1, Insulin and Dextrose 20 % in Water in people with Type 1 Diabetes and Insulin Sensitivity/Resistance, run by University of Virginia at 1 site in United States.
Trial summary
GLP-1 increases skeletal and cardiac microvascular perfusion and improves insulin's microvascular responses in human subjects with T1DM, leading to improved metabolic insulin responses, endothelial function, and increased muscle oxygenation Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes, Insulin Sensitivity/Resistance
- What is being tested?
- GLP-1, Insulin and Dextrose 20 % in Water
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2019to Oct 2024
- Phase
- Early Phase 1
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- History of type 1 diabetes, duration > 1 year
- Age 18-40 years
- HbA1c < 8.5%
- BMI >/=18, <30 kg/m2
- Using insulin for diabetes treatment only
- On stable regimen of non-diabetic medications for the last 6 months, excluding oral contraceptives (OCP)
- All screening labs within normal limits or not clinical significant
Who cannot join
- 1) Pregnancy or currently breastfeeding 2) Smoking history within 6 months 3) History of microvascular (microalbuminuria, retinopathy, neuropathy) or macrovascular diabetes complications (coronary artery disease, stroke, peripheral vascular disease) 4) Taking vasoactive medications (i.e. calcium channel blockers, angiotensin-converting enzyme or renin inhibitors, angiotensin-receptor blockers, nitrates, alpha-blockers) 5) OCP use within 3 months or 1 month if menses has subsequently occurred 6) Known hypersensitivity to perflutren (contained in Definity© contrast) 7) Screening O2 saturation<90% 8) Anemia (hemoglobin <12 g/dL in women, hemoglobin <13 g/dL in men) 9) Diabetic ketoacidosis (DKA) on presentation to screening visits or study admission days
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22906
About this study
GLP-1 increases skeletal and cardiac microvascular perfusion and improves insulin's microvascular responses in human subjects with T1DM, leading to improved metabolic insulin responses, endothelial function, and increased muscle oxygenation
Read the detailed description
The proposed study will determine the effect of GLP-1 infusion on microvascular perfusion and microvascular insulin responses in both skeletal and cardiac muscle microvasculature in humans with T1DM. The investigators will study 20 participants with T1DM using a state-of-the-art technology, contrast enhanced ultrasound (CEU), to assess whether GLP-1 augments skeletal and cardiac microvascular blood flow (MBF) as a representation of microvascular perfusion, flow-mediated dilation (FMD) as a measurement of endothelial function, and augmentation index (AI) and pulse wave velocity (PWV) as surrogates for large vessel compliance. The investigators will use the combined CEU and euglycemic-hyperinsulinemic clamp approach to determine if microvascular and metabolic IR improves as a result.
- Conditions
- Type 1 Diabetes, Insulin Sensitivity/Resistance
- Being tested
- GLP-1, Insulin, Dextrose 20 % in Water
- Medical subject headings
- Diabetes Mellitus, Type 1, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-1Drug
glucagon-like peptide 1
InsulinDrug
we are using to replace basal insulin and to raise insulin concentrations during the insulin clamp
Dextrose 20 % in WaterDrug
We are using Dextrose to maintain Euglycemia during the insulin clamp
| Study group | Role | What they receive |
|---|---|---|
| GLP-1 | Active comparator | GLP-1 infusion 1.2 pmol/kg/min for 150 min Receives: Drug: GLP-1 |
| GLP-1 + Insulin clamp | Active comparator | GLP-1 infusion 1.2 pmol/kg/min for 150 min and insulin 1 mU/kg/min + Dextrose 20% at variable rate to maintain euglycemia for 120 min Receives: Drug: GLP-1; Drug: Insulin; Drug: Dextrose 20 % in Water |
| Saline + Insulin clamp | Active comparator | Saline infusion at 30 ml/hr for 150 min and insulin 1 mU/kg/min + Dextrose 20% at variable rate to maintain euglycemia for 120 min. Receives: Drug: Insulin; Drug: Dextrose 20 % in Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in microvascular blood volume between baseline and 2 hour insulin clamp
vascular measurement
Measured: baseline and after 2 hour insulin clamp
change in insulin sensitivity between baseline and 2 hour insulin clamp
vascular measurement
Measured: baseline and after 2 hour insulin clamp
Secondary outcomes (3)
change in augmentation index between baseline and 2 hour insulin clamp
vascular measurement
Measured: baseline and after 2 hour insulin clamp
change in flow-mediated dilation between baseline and 2 hour insulin clamp
vascular measurement
Measured: baseline and after 2 hour insulin clamp
change in pulse wave velocity between baseline and 2 hour insulin clamp
vascular measurement
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.
- First posted21 Oct 2019
- Study start14 Oct 2019
- Primary completionOct 2023 (estimated)
- Study completionOct 2024 (estimated)
Why it stopped: the study drug could not be obtained
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies 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
- Parallel groups
- Model description
- Each subject is studied 3 times in randomized order
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Zhenqi Liu, University of Virginia
- Investigators
- Zhenqi Liu, MD, Principal investigator, Department of Endocrinology, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04133922
- Sponsor's protocol ID
- 21590
- Other IDs
- 5R01DK102359-03
- Acronym
- KML001
- Status last verified
- Mar 2022
- First submitted
- 15 Oct 2019
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Secrest AM, Becker DJ, Kelsey SF, Laporte RE, Orchard TJ. Cause-specific mortality trends in a large population-based cohort with long-standing childhood-onset type 1 diabetes. Diabetes. 2010 Dec;59(12):3216-22. doi: 10.2337/db10-0862. Epub 2010 Aug 25.
PubMed 20739685Krolewski AS, Kosinski EJ, Warram JH, Leland OS, Busick EJ, Asmal AC, Rand LI, Christlieb AR, Bradley RF, Kahn CR. Magnitude and determinants of coronary artery disease in juvenile-onset, insulin-dependent diabetes mellitus. Am J Cardiol. 1987 Apr 1;59(8):750-5. doi: 10.1016/0002-9149(87)91086-1.
PubMed 3825934Libby P, Nathan DM, Abraham K, Brunzell JD, Fradkin JE, Haffner SM, Hsueh W, Rewers M, Roberts BT, Savage PJ, Skarlatos S, Wassef M, Rabadan-Diehl C; National Heart, Lung, and Blood Institute; National Institute of Diabetes and Digestive and Kidney Diseases Working Group on Cardiovascular Complications of Type 1 Diabetes Mellitus. Report of the National Heart, Lung, and Blood Institute-National Institute of Diabetes and Digestive and Kidney Diseases Working Group on Cardiovascular Complications of Type 1 Diabetes Mellitus. Circulation. 2005 Jun 28;111(25):3489-93. doi: 10.1161/CIRCULATIONAHA.104.529651. No abstract available.
PubMed 15983263Soedamah-Muthu SS, Fuller JH, Mulnier HE, Raleigh VS, Lawrenson RA, Colhoun HM. High risk of cardiovascular disease in patients with type 1 diabetes in the U.K.: a cohort study using the general practice research database. Diabetes Care. 2006 Apr;29(4):798-804. doi: 10.2337/diacare.29.04.06.dc05-1433.
PubMed 16567818Peters SAE, Woodward M. Sex Differences in the Burden and Complications of Diabetes. Curr Diab Rep. 2018 Apr 18;18(6):33. doi: 10.1007/s11892-018-1005-5.
PubMed 29671082Huxley RR, Peters SA, Mishra GD, Woodward M. Risk of all-cause mortality and vascular events in women versus men with type 1 diabetes: a systematic review and meta-analysis. Lancet Diabetes Endocrinol. 2015 Mar;3(3):198-206. doi: 10.1016/S2213-8587(14)70248-7. Epub 2015 Feb 6.
PubMed 25660575Di Carli MF, Afonso L, Campisi R, Ramappa P, Bianco-Batlles D, Grunberger G, Schelbert HR. Coronary vascular dysfunction in premenopausal women with diabetes mellitus. Am Heart J. 2002 Oct;144(4):711-8.
PubMed 12360169Mendelsohn ME, Karas RH. The protective effects of estrogen on the cardiovascular system. N Engl J Med. 1999 Jun 10;340(23):1801-11. doi: 10.1056/NEJM199906103402306. No abstract available.
PubMed 10362825Bjornstad P, Maahs DM, Duca LM, Pyle L, Rewers M, Johnson RJ, Snell-Bergeon JK. Estimated insulin sensitivity predicts incident micro- and macrovascular complications in adults with type 1 diabetes over 6 years: the coronary artery calcification in type 1 diabetes study. J Diabetes Complications. 2016 May-Jun;30(4):586-90. doi: 10.1016/j.jdiacomp.2016.02.011. Epub 2016 Feb 11.
PubMed 26936306Baron AD. Hemodynamic actions of insulin. Am J Physiol. 1994 Aug;267(2 Pt 1):E187-202. doi: 10.1152/ajpendo.1994.267.2.E187.
PubMed 8074198Millstein RJ, Pyle LL, Bergman BC, Eckel RH, Maahs DM, Rewers MJ, Schauer IE, Snell-Bergeon JK. Sex-specific differences in insulin resistance in type 1 diabetes: The CACTI cohort. J Diabetes Complications. 2018 Apr;32(4):418-423. doi: 10.1016/j.jdiacomp.2018.01.002. Epub 2018 Jan 10.
PubMed 29449137DeFronzo RA, Hendler R, Simonson D. Insulin resistance is a prominent feature of insulin-dependent diabetes. Diabetes. 1982 Sep;31(9):795-801. doi: 10.2337/diab.31.9.795. No abstract available.
PubMed 6761214Kaul K, Apostolopoulou M, Roden M. Insulin resistance in type 1 diabetes mellitus. Metabolism. 2015 Dec;64(12):1629-39. doi: 10.1016/j.metabol.2015.09.002. Epub 2015 Sep 11.
PubMed 26455399Priya G, Kalra S. A Review of Insulin Resistance in Type 1 Diabetes: Is There a Place for Adjunctive Metformin? Diabetes Ther. 2018 Feb;9(1):349-361. doi: 10.1007/s13300-017-0333-9. Epub 2017 Nov 14.
PubMed 29139080Gao F, Gao E, Yue TL, Ohlstein EH, Lopez BL, Christopher TA, Ma XL. Nitric oxide mediates the antiapoptotic effect of insulin in myocardial ischemia-reperfusion: the roles of PI3-kinase, Akt, and endothelial nitric oxide synthase phosphorylation. Circulation. 2002 Mar 26;105(12):1497-502. doi: 10.1161/01.cir.0000012529.00367.0f.
PubMed 11914261
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of GLP-1 on Microvascular Insulin Responses in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04133922
- Acronym / sponsor ID
- KML001 / 21590
- Conditions
- Type 1 Diabetes, Insulin Sensitivity/Resistance
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: the study drug could not be obtained
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- American Diabetes Association, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 21 Oct 2019 (actual)
- 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.
GLP-1 increases skeletal and cardiac microvascular perfusion and improves insulin's microvascular responses in human subjects with T1DM, leading to improved metabolic insulin responses, endothelial function, and increased muscle oxygenation
Detailed description
The proposed study will determine the effect of GLP-1 infusion on microvascular perfusion and microvascular insulin responses in both skeletal and cardiac muscle microvasculature in humans with T1DM. The investigators will study 20 participants with T1DM using a state-of-the-art technology, contrast enhanced ultrasound (CEU), to assess whether GLP-1 augments skeletal and cardiac microvascular blood flow (MBF) as a representation of microvascular perfusion, flow-mediated dilation (FMD) as a measurement of endothelial function, and augmentation index (AI) and pulse wave velocity (PWV) as surrogates for large vessel compliance. The investigators will use the combined CEU and euglycemic-hyperinsulinemic clamp approach to determine if microvascular and metabolic IR improves as a result.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Each subject is studied 3 times in randomized order
| Arm | Type | Receives |
|---|---|---|
| GLP-1 | Active comparator | Drug: GLP-1GLP-1 infusion 1.2 pmol/kg/min for 150 min |
| GLP-1 + Insulin clamp | Active comparator | Drug: GLP-1, Drug: Insulin, Drug: Dextrose 20 % in WaterGLP-1 infusion 1.2 pmol/kg/min for 150 min and insulin 1 mU/kg/min + Dextrose 20% at variable rate to maintain euglycemia for 120 min |
| Saline + Insulin clamp | Active comparator | Drug: Insulin, Drug: Dextrose 20 % in WaterSaline infusion at 30 ml/hr for 150 min and insulin 1 mU/kg/min + Dextrose 20% at variable rate to maintain euglycemia for 120 min. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- History of type 1 diabetes, duration > 1 year
- Age 18-40 years
- HbA1c < 8.5%
- BMI >/=18, <30 kg/m2
- Using insulin for diabetes treatment only
Key exclusion criteria (2 listed)
- 1) Pregnancy or currently breastfeeding 2) Smoking history within 6 months 3) History of microvascular (microalbuminuria, retinopathy, neuropathy) or macrovascular diabetes complications (coronary artery disease, stroke, peripheral vascular disease) 4) Taking vasoactive medications (i.e. calcium channel blockers, angiotensin-converting enzyme or renin inhibitors, angiotensin-receptor blockers, nitrates, alpha-blockers) 5) OCP use within 3 months or 1 month if menses has subsequently occurred 6) Known hypersensitivity to perflutren (contained in Definity© contrast) 7) Screening O2 saturation<90% 8) Anemia (hemoglobin <12 g/dL in women, hemoglobin <13 g/dL in men) 9) Diabetic ketoacidosis (DKA) on presentation to screening visits or study admission days
- -
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 |
|---|---|---|
| GLP-1glucagon-like peptide 1 | Drug | GLP-1, GLP-1 + Insulin clamp |
| Insulinwe are using to replace basal insulin and to raise insulin concentrations during the insulin clamp | Drug | GLP-1 + Insulin clamp, Saline + Insulin clamp |
| Dextrose 20 % in WaterWe are using Dextrose to maintain Euglycemia during the insulin clamp | Drug | GLP-1 + Insulin clamp, Saline + Insulin clamp |
Primary outcome
change in microvascular blood volume between baseline and 2 hour insulin clamp
Time frame: baseline and after 2 hour insulin clamp
vascular measurement
change in insulin sensitivity between baseline and 2 hour insulin clamp
Time frame: baseline and after 2 hour insulin clamp
vascular measurement
3 secondary outcomes
change in augmentation index between baseline and 2 hour insulin clamp
Time frame: baseline and after 2 hour insulin clamp
change in flow-mediated dilation between baseline and 2 hour insulin clamp
Time frame: baseline and after 2 hour insulin clamp
change in pulse wave velocity between baseline and 2 hour insulin clamp
Time frame: baseline and after 2 hour insulin clamp
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 22 Mar 2022.
- Background: PubMed 20739685Secrest AM, Becker DJ, Kelsey SF, Laporte RE, Orchard TJ. Cause-specific mortality trends in a large population-based cohort with long-standing childhood-onset type 1 diabetes. Diabetes. 2010 Dec;59(12):3216-22. doi: 10.2337/db10-0862. Epub 2010 Aug 25.
- Background: PubMed 3825934Krolewski AS, Kosinski EJ, Warram JH, Leland OS, Busick EJ, Asmal AC, Rand LI, Christlieb AR, Bradley RF, Kahn CR. Magnitude and determinants of coronary artery disease in juvenile-onset, insulin-dependent diabetes mellitus. Am J Cardiol. 1987 Apr 1;59(8):750-5. doi: 10.1016/0002-9149(87)91086-1.
- Background: PubMed 15983263Libby P, Nathan DM, Abraham K, Brunzell JD, Fradkin JE, Haffner SM, Hsueh W, Rewers M, Roberts BT, Savage PJ, Skarlatos S, Wassef M, Rabadan-Diehl C; National Heart, Lung, and Blood Institute; National Institute of Diabetes and Digestive and Kidney Diseases Working Group on Cardiovascular Complications of Type 1 Diabetes Mellitus. Report of the National Heart, Lung, and Blood Institute-National Institute of Diabetes and Digestive and Kidney Diseases Working Group on Cardiovascular Complications of Type 1 Diabetes Mellitus. Circulation. 2005 Jun 28;111(25):3489-93. doi: 10.1161/CIRCULATIONAHA.104.529651. No abstract available.
- Background: PubMed 16567818Soedamah-Muthu SS, Fuller JH, Mulnier HE, Raleigh VS, Lawrenson RA, Colhoun HM. High risk of cardiovascular disease in patients with type 1 diabetes in the U.K.: a cohort study using the general practice research database. Diabetes Care. 2006 Apr;29(4):798-804. doi: 10.2337/diacare.29.04.06.dc05-1433.
- Background: PubMed 29671082Peters SAE, Woodward M. Sex Differences in the Burden and Complications of Diabetes. Curr Diab Rep. 2018 Apr 18;18(6):33. doi: 10.1007/s11892-018-1005-5.
- Background: PubMed 25660575Huxley RR, Peters SA, Mishra GD, Woodward M. Risk of all-cause mortality and vascular events in women versus men with type 1 diabetes: a systematic review and meta-analysis. Lancet Diabetes Endocrinol. 2015 Mar;3(3):198-206. doi: 10.1016/S2213-8587(14)70248-7. Epub 2015 Feb 6.
- Background: PubMed 12360169Di Carli MF, Afonso L, Campisi R, Ramappa P, Bianco-Batlles D, Grunberger G, Schelbert HR. Coronary vascular dysfunction in premenopausal women with diabetes mellitus. Am Heart J. 2002 Oct;144(4):711-8.
- Background: PubMed 10362825Mendelsohn ME, Karas RH. The protective effects of estrogen on the cardiovascular system. N Engl J Med. 1999 Jun 10;340(23):1801-11. doi: 10.1056/NEJM199906103402306. No abstract available.
- Background: PubMed 26936306Bjornstad P, Maahs DM, Duca LM, Pyle L, Rewers M, Johnson RJ, Snell-Bergeon JK. Estimated insulin sensitivity predicts incident micro- and macrovascular complications in adults with type 1 diabetes over 6 years: the coronary artery calcification in type 1 diabetes study. J Diabetes Complications. 2016 May-Jun;30(4):586-90. doi: 10.1016/j.jdiacomp.2016.02.011. Epub 2016 Feb 11.
- Background: PubMed 8074198Baron AD. Hemodynamic actions of insulin. Am J Physiol. 1994 Aug;267(2 Pt 1):E187-202. doi: 10.1152/ajpendo.1994.267.2.E187.
- Background: PubMed 29449137Millstein RJ, Pyle LL, Bergman BC, Eckel RH, Maahs DM, Rewers MJ, Schauer IE, Snell-Bergeon JK. Sex-specific differences in insulin resistance in type 1 diabetes: The CACTI cohort. J Diabetes Complications. 2018 Apr;32(4):418-423. doi: 10.1016/j.jdiacomp.2018.01.002. Epub 2018 Jan 10.
- Background: PubMed 6761214DeFronzo RA, Hendler R, Simonson D. Insulin resistance is a prominent feature of insulin-dependent diabetes. Diabetes. 1982 Sep;31(9):795-801. doi: 10.2337/diab.31.9.795. No abstract available.
Related trials for Type 1 Diabetes
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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.
Zhenqi Liu, MD principal investigator
Department of Endocrinology, University of Virginia
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 GLP-1, Insulin and Dextrose 20 % in Water in people with Type 1 Diabetes and Insulin Sensitivity/Resistance, 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 7 inclusion and 2 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 22 Mar 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?
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?
change in microvascular blood volume between baseline and 2 hour insulin clamp (time frame: baseline and after 2 hour insulin clamp). The study lists 2 primary outcomes in all. 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 NCT04133922, which also lists 30 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 22 Mar 2022.