Metabolic Adaptation to Diabetes
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Purpose
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 | Intervention |
|---|---|
|
Type 2 Diabetes |
Procedure: glucose clamp |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Metabolic Adaptation to Diabetes |
- HbA1c [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Catecholamines [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 15 |
| Study Start Date: | February 1998 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | March 2000 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 30 Years to 65 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Stephen N. Davis, MD, Vanderbilt University/Veterans Administration |
| ClinicalTrials.gov Identifier: | NCT00732862 History of Changes |
| Other Study ID Numbers: | IRB#8842-NIDDM |
| Study First Received: | August 8, 2008 |
| Last Updated: | June 23, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by 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 |
ClinicalTrials.gov processed this record on May 19, 2013