Completed

Neuroendocrine Response to Hypoglycemia in NIDDM Patients

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

This study aims to understand the neuroendocrine response to low blood sugar levels in individuals with Non-Insulin Dependent Diabetes Mellitus (NIDDM), by measuring HbA1c levels.

What is being tested

glucose clamp

Procedure
Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

From 30 to 65 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: February 1998
See protocol details

Summary

Principal SponsorVanderbilt University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 1998

Actual date on which the first participant was enrolled.

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.

Official TitleMetabolic Adaptation to Diabetes
NCT00732862
Principal SponsorVanderbilt University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

15 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 30 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

2 inclusion criteria required to participate
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

3 exclusion criteria prevent from participating
Prior or current history of poor health

Abnormal results following screening tests

Pregnancy

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Baseline clamp study before treatment phase.

Group II

Active Comparator
Final clamp experiment after 6 months intensive therapy.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers