Diagnosing and Treating Low Blood Sugar Levels
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hypoglycemia, Insulinoma. Basic parameters: 18 years — 120 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Fasting Hypoglycemia: Diagnosis and Treatment
Overview
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.
Detailed 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
Primary outcome measures
- Treatment Outcomes [Time frame: every 1-3 months]
Eligibility criteria
- INCLUSION CRITERIA:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Male, females ages >= 18.
- 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:
- Patients with significant cardiac disease will be excluded.
- Subjects who are pregnant per self-report.
- Medically unstable per the assessment of the PI.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- National Institutes of Health Clinical Center — Bethesda
Publications
- 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. PMID 194912
- 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. PMID 6349454
- Comi RJ, Gorden P. Approach to hypoglycemia in adults. Compr Ther. 1987 Mar;13(3):38-44. No abstract available. PMID 3568598
Identifiers
NCT: NCT00001276 · 910066 · 91-DK-0066