NCT00732862

Brief Summary

Hypoglycemia or low blood sugar is a very serious complication that diabetics experience. This is of great concern because there is a lack of available information of how Non Insulin Dependent Diabetic Mellitus patients (NIDDM) defend themselves against a low blood sugar. This is particularly disturbing since NIDDM patients are likely to require intensive treatment, and as a result, the risks of severe hypoglycemia to the NIDDM patient increase. The current proposal aims to provide information on how NIDDM patients can defend themselves against hypoglycemia, thus decreasing their risks for this severe complication.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Feb 1998

Longer than P75 for not_applicable type-2-diabetes

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

February 1, 1998

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2000

Completed
8.4 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

December 11, 2014

Status Verified

December 1, 2014

Enrollment Period

2.1 years

First QC Date

August 8, 2008

Last Update Submit

December 10, 2014

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetesintensive therapy

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    6 months

Secondary Outcomes (1)

  • Catecholamines

    6 months

Study Arms (2)

1

EXPERIMENTAL

Baseline clamp study before treatment phase.

Procedure: glucose clamp

2

ACTIVE COMPARATOR

Final clamp experiment after 6 months intensive therapy.

Procedure: glucose clamp

Interventions

glucose clampPROCEDURE

Hyperinsulinemic Hypoglycemic clamp

1

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy male and female subjects aged 30-65 years
  • Male and female non-insulin-dependent diabetic patients, sulfonylurea and/or Metformin aged 30-65 years

You may not qualify if:

  • Prior or current history of poor health
  • Abnormal results following screening tests
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Glucose Clamp Technique

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine 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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman of Medicine, University of Maryland, Baltimore

Study Record Dates

First Submitted

August 8, 2008

First Posted

August 12, 2008

Study Start

February 1, 1998

Primary Completion

March 1, 2000

Study Completion

December 1, 2008

Last Updated

December 11, 2014

Record last verified: 2014-12