Differing Levels of Hypoglycemia

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT02445781
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Hypoglycemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Glucose clamp — DEVICE
    Different levels of hypoglycemia

Study Details

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.

Key Dates

Start date
Jul 31, 2015
Status verified
Nov 2025
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: 90 mg/dl glucose clamp
    Glucose clamp intervention of 90 mg/dl maintained for 90 minutes.
  • Experimental: 70 mg/dl glucose clamp
    Glucose clamp intervention of 70 mg/dl maintained for 90 minutes.
  • Experimental: 60 mg/dl glucose clamp
    Glucose clamp intervention of 60 mg/dl maintained for 90 minutes.
  • Experimental: 50 mg/dl glucose clamp
    Glucose clamp intervention of 50 mg/dl maintained for 90 minutes.

Primary Outcome Measure

Flow mediated vasodilation of brachial artery measurements (mean maximum % change) [ Time Frame: 120 minutes (pre) clamp and 240 minutes (post) clamp ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Maryland, BaltimoreBaltimoreMaryland21201
Maka Siamashvili, MD
410-706-5623
Stephen N Davis, MBBS (PRINCIPAL_INVESTIGATOR)
University of Maryland, BaltimoreBaltimoreMaryland21201
Maka Siamashvili, MD
410-706-5623
Maka Hedrington, MD
[email protected]
410-706-5623
Stephen N Davis, MBBS (PRINCIPAL_INVESTIGATOR)

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