Metabolic Adaptation to Diabetes

Type 2 Diabetes Clinical Trial

Official title:

Metabolic Adaptation to Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00732862
• Other study ID #: IRB#8842-NIDDM
• Status: Completed
• Phase: N/A
• First received: August 8, 2008
• Last updated: December 10, 2014
• Start date: February 1998
• Est. completion date: December 2008

Study information

• Verified date: December 2014
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2008
• Est. primary completion date: March 2000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Procedure:
• glucose clamp
Hyperinsulinemic Hypoglycemic clamp
• glucose clamp
Hyperinsulinemic Hypoglycemic clamp

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Vanderbilt University	Juvenile Diabetes Research Foundation, VA Office of Research and Development

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c		6 months	No
Secondary	Catecholamines		6 months	No