NCT00742521

Brief Summary

It has been found that in some cases, when a person with Diabetes Mellitus has an episode of low blood sugar,or hypoglycemia, and then later exercises, he or she is vulnerable to another bout of hypoglycemia during that exercise. The purpose of this study is to determine what factors during the previous bout of hypoglycemia might cause another bout of hypoglycemia while exercising later.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

March 1, 2001

Completed
7.5 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

June 10, 2015

Status Verified

June 1, 2015

Enrollment Period

7.7 years

First QC Date

August 25, 2008

Last Update Submit

June 9, 2015

Conditions

Type 1 Diabetes

Keywords

cortisolcatecholaminesType 1 DM

Outcome Measures

Primary Outcomes (1)

  • catecholamine measures

    8 months

Study Arms (4)

1

ACTIVE COMPARATOR

Euglycemic glucose clamp procedure x 2 on Day 1 and hypoglycemic glucose clamp procedure on Day 2. Control study

Procedure: glucose clamp

2

ACTIVE COMPARATOR

Hypoglycemic glucose clamp procedure x 2 on Day 1 and hypoglycemic glucose clamp procedure on Day 2. Control study

Procedure: glucose clamp

3

ACTIVE COMPARATOR

Euglycemic glucose clamp procedure x 2 with cortisol infusion of 2ug/kg on Day 1 and hypoglycemic glucose clamp procedure on Day 2.

Procedure: glucose clamp

4

ACTIVE COMPARATOR

Hyperinsulinemic euglycemic glucose clamp procedure x 2 with cortisol infusion at 1 ug/kg on Day 1 and hyperinsulinemic hypoglycemic glucose clamp procedure on Day 2.

Procedure: glucose clamp

Interventions

glucose clampPROCEDURE

Day 1 hyperinsulinemic euglycemic glucose clamp procedure x 2 and Day 2 hyperinsulinemic hypoglycemic glucose clamp procedure

1

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Males and females with Type 1 Diabetes Mellitus will be studied. Subjects recruited will be 18-50 years, with an HBA1c less than 9.5%, who have been diagnosed with diabetes for \>5 years, with no clinical evidence of diabetic tissue complications.

You may not qualify if:

  • all medical students (Vanderbilt policy)
  • prior or current history of poor health
  • abnormal results following blood and physical examination
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Glucose Clamp Technique

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Stephen N Davis, MD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman of Medicine

Study Record Dates

First Submitted

August 25, 2008

First Posted

August 27, 2008

Study Start

March 1, 2001

Primary Completion

November 1, 2008

Study Completion

June 1, 2009

Last Updated

June 10, 2015

Record last verified: 2015-06

Locations

US(1)