Metabolic Adaptation to Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00732862
Recruitment Status : Completed
First Posted : August 12, 2008
Last Update Posted : December 11, 2014
VA Office of Research and Development
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Steve Davis, Vanderbilt University

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Procedure: glucose clamp Not Applicable

Detailed Description:
There is very little data available on the neuroendocrine response to hypoglycemia in intensively treated (sulfonylurea or insulin) NIDDM patients. The data that are available on the neuroendocrine response to hypoglycemia in NIDDM patients were obtained under conditions following a single IV bolus of insulin or single SQ regular insulin injection. The neuroendocrine response following a large IV bolus of insulin differs greatly from the clinical paradigm of a slow progression into hypoglycemia. Therefore, clinically relevant data cannot be obtained from short experiments involving rapid changes in plasma glucose levels and insulinemia. Furthermore, a comparison between neuroendocrine responses to hypoglycemia in NIDDM and normal man is not available due to the fact that glycemia has never been equally controlled. In short, virtually nothing is known about the neuroendocrine response to hypoglycemia in these subjects. This is of great concern as following the positive outcome of the Kumamato study, large numbers of NIDDM subjects are going to receive intensive therapy with all its altendent risks of severe hypoglycemia. The Kumamato study was a trial in NIDDM patients to determine if intensive therapy reduces tissue complications of diabetes. Similar to the results of the Diabetes control and complications trial in IDDM patients the Kumamato study proved that intensive therapy in NIDDM patients also prevents diabetic tissue complications. Therefore, the goals of this study are 1) to define in greater detail how the body defends itself against hypoglycemia in NIDDM patients and 2) to determine if differing levels of insulin affect hypoglycemic counterregulation in NIDDM patients.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Metabolic Adaptation to Diabetes
Study Start Date : February 1998
Actual Primary Completion Date : March 2000
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Baseline clamp study before treatment phase.
Procedure: glucose clamp
Hyperinsulinemic Hypoglycemic clamp

Active Comparator: 2
Final clamp experiment after 6 months intensive therapy.
Procedure: glucose clamp
Hyperinsulinemic Hypoglycemic clamp

Primary Outcome Measures :
  1. HbA1c [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Catecholamines [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00732862

Sponsors and Collaborators
Vanderbilt University
VA Office of Research and Development
Juvenile Diabetes Research Foundation
Principal Investigator: Stephen N Davis, MD Vanderbilt University

Responsible Party: Steve Davis, Chairman of Medicine, University of Maryland, Baltimore, Vanderbilt University Identifier: NCT00732862     History of Changes
Other Study ID Numbers: IRB#8842-NIDDM
First Posted: August 12, 2008    Key Record Dates
Last Update Posted: December 11, 2014
Last Verified: December 2014

Keywords provided by Steve Davis, Vanderbilt University:
Type 2 diabetes
intensive therapy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases