Diagnosing and Treating Low Blood Sugar Levels

Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
Overall Status
Recruiting
CT.gov ID
NCT00001276
Collaborator
(none)
1,500
1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The purpose of this protocol is to continue our studies of the evaluation and treatment of patients with fasting hypoglycemia due to diverse etiologies. Patients will be admitted to the Clinical Research Center under this protocol and undergo supervised fasting, dynamic tests of insulin secretion when appropriate, medically indicated imaging studies, and appropriate medical and surgical treatment.

    The goals of this study are:
    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Fasting Hypoglycemia: Diagnosis and Treatment
    Actual Study Start Date :
    Jul 17, 1995

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with hypoglycemia

    Patients with hypoglycemia due to diverse etiologies.

    Outcome Measures

    Primary Outcome Measures

    1. Treatment Outcomes [every 1-3 months]

      resolution of hypoglycemia

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • 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.

    3. Patients with biochemical evidence for insulinoma or other neuroendocrine tumors.

    EXCLUSION CRITERIA:

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

    1. Patients with known sulfa allergies and patients with significant cardiac disease will be excluded.

    2. Subjects who are pregnant.

    3. Medically unstable per the assessment of the PI.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland United States 20892

    Sponsors and Collaborators

    • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    Investigators

    • Principal Investigator: Ranganath Muniyappa, M.D., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    ClinicalTrials.gov Identifier:
    NCT00001276
    Other Study ID Numbers:
    • 910066
    • 91-DK-0066
    First Posted:
    Nov 4, 1999
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Mar 11, 2022
    Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 25, 2022