NCT02445781

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for early_phase_1

Timeline
7mo left

Started Jul 2015

Longer than P75 for early_phase_1

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jul 2015Dec 2026

First Submitted

Initial submission to the registry

May 8, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 15, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
11.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

November 10, 2025

Status Verified

November 1, 2025

Enrollment Period

11.2 years

First QC Date

May 8, 2015

Last Update Submit

November 5, 2025

Conditions

Hypoglycemia

Outcome Measures

Primary Outcomes (1)

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

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

    120 minutes (pre) clamp and 240 minutes (post) clamp

Study Arms (4)

90 mg/dl glucose clamp

EXPERIMENTAL

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

Device: Glucose clamp

70 mg/dl glucose clamp

EXPERIMENTAL

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

Device: Glucose clamp

60 mg/dl glucose clamp

EXPERIMENTAL

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

Device: Glucose clamp

50 mg/dl glucose clamp

EXPERIMENTAL

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

Device: Glucose clamp

Interventions

Glucose clampDEVICE

Different levels of hypoglycemia

50 mg/dl glucose clamp60 mg/dl glucose clamp70 mg/dl glucose clamp90 mg/dl glucose clamp

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index \>21kg · m-2

You may not qualify if:

  • Pregnant women
  • Subjects unwilling or unable to comply with approved contraception measures
  • Subjects unable to give voluntary informed consent
  • 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
  • Uncontrolled severe hypertension (i.e., blood pressure greater than 160/100)
  • Clinically significant 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
  • Hematocrit lower than 32 %
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

RECRUITING

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

RECRUITING

MeSH Terms

Conditions

Hypoglycemia

Interventions

Glucose Clamp Technique

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisChemistry Techniques, AnalyticalInvestigative Techniques

Central Study Contacts

Maka Siamashvili, MD

CONTACT

410-706-5623msiamashvili@som.umaryland.edu

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman of Medicine

Study Record Dates

First Submitted

May 8, 2015

First Posted

May 15, 2015

Study Start

July 1, 2015

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

November 10, 2025

Record last verified: 2025-11

Locations

US(2)