ClinicalTrials.gg
CompletedNCT02445781Updated Nov 6, 2026

Differing Levels of Hypoglycemia

An Early Phase 1 interventional study of Glucose clamp in Hypoglycemia, sponsored by University of Maryland, Baltimore. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by University of Maryland, Baltimore · Early Phase 1, Interventional, and Treatment

Updated Nov 6, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓
Phase
Early Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 294 studies in Hypoglycemia with a site in United States — 36 open to participants now, 49 under way, 5 of them phase 3. Hypoglycemia · United States.

Planned enrollment
101st of 239
32 · median 24
Started
2015
with 17 others
Phase 1
32 of 294
5 open now
Registered
131st of 294
by date

Among the 294 studies in Hypoglycemia with a site in United States, this one is the 101st largest by planned enrollment of the 239 interventional ones that give a count, is one of 18 that started in 2015, is one of 32 in phase 1, and was the 131st registered.

Hypoglycemia

706 studies on the registry are indexed under Hypoglycemia; 94 are open to participants now.

Browse Hypoglycemia studies →

Open to participants now

36 of the 294 studies in Hypoglycemia with a site in United States are open now. Recruiting first, the newest first:

31 more — sign in →

All 36 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 59 Hypoglycemia studies recruiting now, 23 (39%) set no upper age limit and 31 (53%) stop at 75 or younger; 18 take children under 18; 14 take healthy volunteers.

This study: 18 Years to 55 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 294 studies in Hypoglycemia with a site in United States, or all of them as a file.
02

Study summary

Hypoglycemia can produce a spectrum of pro-inflammatory and pro-atherothrombotic changes. To date no studies appear to have investigated the effects of differing levels of hypoglycemia on the vasculature and pro-atherothrombotic balance during hypoglycemia in healthy man. The specific aim of our study will be to determine the effects of differing levels of hypoglycemia on in-vivo vascular biologic mechanisms in a healthy population.

Read the detailed description

Recent large randomized multicenter trials have investigated the effects of lowering blood glucose levels towards normal in both inpatient and ambulatory care/community settings. All studies have reported increasing prevalence and incidence of hypoglycemia as glucose levels approach normal. In fact, the occurrence of hypoglycemia was so problematic that some hospital based studies were halted and the target recommendations for glucose levels in critically unwell patients have been increased. Similarly three recent large glucose control and complications trials in type 2 diabetes mellitus (DM) have reported significantly high rates of hypoglycemia in intensively treated type 2 DM individuals. In two of these studies (VADT, ADVANCE) there was a highly significant association between severe hypoglycemia (glucose low enough to cause neurologic impairment) and serious cardiac events and increased death. Furthermore, in two studies performed in the USA (VADT, ACCORD), severe hypoglycemia occurring in the standard/conventionally treated group produced even more serious adverse cardiac effects as compared to the intensively treated group. The in-vivo mechanism(s) responsible for the above findings could not be identified from the above studies. Surprisingly there is very limited data available regarding the effects of hypoglycemia on in-vivo vascular biology. Previously, in vitro work has determined that epinephrine, norepinephrine, growth hormone, glucagon, and corticosteroids (all counterregulatory hormones) can have vascular biologic effects (platelet aggregation, fibrinolytic balance, increases in pro-inflammatory markers and changes in endothelial function). Three recent studies from my own and other laboratories performed in healthy volunteers and type 1 DM have demonstrated that hypoglycemia can produce a spectrum of pro-inflammatory and pro-atherothrombotic changes. Novel preliminary data from my lab has also demonstrated that hypoglycemia can impair endothelial function, reduce fibrinolytic balance (increase plasminogen activator inhibitor-1) and produce pro-atherothrombotic (increase platelet aggregation, thrombin anti-thrombin complexes, vascular adhesion molecules) changes in type 2 DM. Additionally, preliminary data presented below will demonstrate that a 90 minute episode of hypoglycemia (50 mg/dl) produces similar pro-atherothrombotic changes as compared to 4 hours of hyperglycemia (200 mg/dl). However, as investigators are just beginning to realize the effects of hypoglycemia on vascular biology, there remain many unanswered questions. For example, in the vulnerable type 2 DM population what is the dose response of different levels of hypoglycemia with attendant ANS activation on endothelial function and atherothrombotic balance? How does level of glycemic control affect ANS and vascular biologic responses to hypoglycemia in type 2 DM? Proposed studies in this protocol will provide novel information answering the clinically important question regarding the effects of mild to moderate hypoglycemia on vascular biologic mechanisms in a healthy population.

03

Conditions studied

  • Hypoglycemia

Browse trials for

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • >21kg · m-2

Exclusion criteria

Exclusion Criteria:

  • Pregnant women
  • Subjects unwilling or unable to comply with approved measures
  • Subjects unable to give voluntary
  • Subjects on anticoagulant drugs, anemic or with known bleeding diatheses
  • Subjects with a history of severe, uncontrolled hypertension, heart disease, cerebrovascular incidents
  • Current tobacco use
  • Subjects with any known allergies to any of the study medications being used

Physical Exam Exclusion Criteria

  • Uncontrolled severe hypertension (i.e., blood pressure greater than 160/100)
  • cardiac abnormalities (e.g. heart failure, arrhythmia)
  • Pneumonia treatment or hospitalization within 2 weeks prior to enrollment (study visit)
  • Hepatic failure / jaundice
  • Renal failure
  • Cerebrovascular accident occurrence or hospitalization within 4 weeks prior to enrollment
  • Fever greater than 38.0 degrees C

Screening Laboratory Tests Exclusion Criteria

  • Hematocrit lower than 32 %
  • White blood cell (WBC) count lower than 3 thou/ul or greater than 14 thou/ul
  • Liver function tests: serum glutamic oxaloacetic transaminase () and serum glutamic-pyruvic transaminase (SGPT) greater than twice
  • Alkaline phosphatase greater than 150U/L
  • Total (TBil) greater than 2 mg/dl
  • Estimated (eGFR) less than 60 mL/min/1.73 m2
  • Positive (HIV), or
  • Any abnormal cardiac response during multi-stage exercise test (if over 40 years of age)
Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    90 mg/dl glucose clamp

    Glucose clamp intervention of 90 mg/dl maintained for 90 minutes.

    Device: Glucose clamp

  • Experimental
    70 mg/dl glucose clamp

    Glucose clamp intervention of 70 mg/dl maintained for 90 minutes.

    Device: Glucose clamp

  • Experimental
    60 mg/dl glucose clamp

    Glucose clamp intervention of 60 mg/dl maintained for 90 minutes.

    Device: Glucose clamp

  • Experimental
    50 mg/dl glucose clamp

    Glucose clamp intervention of 50 mg/dl maintained for 90 minutes.

    Device: Glucose clamp

Interventions

  • DeviceGlucose clamp

    Different levels of hypoglycemia

06

What researchers measure

Primary outcomes

  1. Flow mediated vasodilation of brachial artery measurements (mean maximum % change)

    baseline (pre) measurements compared to end of clamp (post) measurements

    Time frame: 120 minutes (pre) clamp and 240 minutes (post) clamp

07

Study locations

1 site
08

Timeline

1 registry update since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimatedDate before it movedWhere the date was before it moved

The record gives a start of Jul 2015, a primary completion of Feb 2026 and a completion of Feb 2026. It does not say whether these dates are actual or estimated.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 6, 2026: primary completion Sep 2026 → Feb 2026 and completion Dec 2026 → Feb 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
May 8, 2015
First posted
May 15, 2015
Start
Jul 2015
Primary completionActual
Feb 2026was Sep 2026
CompletionActual
Feb 2026was Dec 2026
Last update
Nov 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Nov 6, 2026
Sites
1 site removed
Show 1 removed
  • University of Maryland, Baltimore · Baltimore, United States
Nov 6, 2026
Primary completion
Sep 2026→Feb 2026 (actual)
Nov 6, 2026
Study completion
Dec 2026→Feb 2026 (actual)
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    Recruiting→Completed
    1 site removed
    Show 1 removed
    • University of Maryland, Baltimore · Baltimore, United States
    Primary completion Sep 2026→Feb 2026 (now actual)
    Study completion Dec 2026→Feb 2026 (now actual)
    + 1 other change: contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT02445781
Responsible party
Stephen N. Davis, MBBS (Chairman of Medicine, University of Maryland, Baltimore) — Principal investigator
First posted
May 15, 2015
Start date
Jul 2015
Primary completion
Feb 2026
Completion
Feb 2026
Last update
Nov 6, 2026

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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