Diagnosing and Treating Low Blood Sugar Levels

Hypoglycemia Clinical Trial

Official title:

Fasting Hypoglycemia: Diagnosis and Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00001276
• Other study ID #: 910066
• Secondary ID: 91-DK-0066
• Status: Recruiting
• Start date: May 21, 1991

Study information

• Verified date: February 1, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Craig S Cochran, R.N.
• Phone: (301) 402-1880
• Email: craigc[@]bdg10.niddk.nih.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Hypoglycemia is the term used to refer to lower than normal levels of blood sugar. This study will continue to research the causes of hypoglycemia.

Patients involved in the study will be admitted to the Clinical Center of the National Institutes of Health and undergo tests for evaluating blood sugar. Patients will be required to refrain from eating for a set period of time and will undergo blood tests for insulin levels and several other specific diagnostic tests related to insulin secretion. The patients will be under supervision and will be provided with appropriate medical and surgical attention as needed.

Description:

Study Description:

The purpose of this study is to gain knowledge and experience in the diagnosis and therapy of patients with fasting hypoglycemia due to diverse etiologies, such as insulinomas. Study subjects will be evaluated and treated for their particular condition according to standard care.

Objectives:

1. To understand the pathophysiology and various causes of hypoglycemia (e.g., insulinomas, MEN1, MEN2).

2. To identify new circulating biomarkers of insulinomas.

3. To create a repository of clinical data and samples for future research of insulinomas.

Endpoints: None

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

• INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Male, females ages >= 18.

2. Patients with documented fasting blood glucose below 55 mg/dl.

4. Patients with biochemical evidence for insulinoma or other pancreatic neuroendocrine tumors.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Patients with significant cardiac disease will be excluded.

2. Subjects who are pregnant per self-report.

3. Medically unstable per the assessment of the PI.

Related Conditions & MeSH terms

• Hypoglycemia
• Insulinoma

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Bar RS, Gorden P, Roth J, Siebert CW. Insulin receptors in patients with insulinomas: changes in receptor affinity and concentration. J Clin Endocrinol Metab. 1977 Jun;44(6):1210-3. doi: 10.1210/jcem-44-6-1210. — View Citation

Blackshear PJ, Rotner HE, Kriauciunas KA, Kahn CR. Reactive hypoglycemia and insulin autoantibodies in drug-induced lupus erythematosus. Ann Intern Med. 1983 Aug;99(2):182-4. doi: 10.7326/0003-4819-99-2-182. — View Citation

Comi RJ, Gorden P. Approach to hypoglycemia in adults. Compr Ther. 1987 Mar;13(3):38-44. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Outcomes	resolution of hypoglycemia	every 1-3 months

External Links

•   NIH Clinical Center Detailed Web Page