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RecruitingNCT00001276Updated Oct 20, 2026

Diagnosing and Treating Low Blood Sugar Levels

An observational study in Hypoglycemia and Insulinoma, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Recruiting at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Observational

From the registry’s dates

  • Started May 1991; still recruiting 35 years 5 months later.
Updated Oct 20, 2026Study contact changedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,500
Ages
18 Years to 120 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Hypoglycemia
  • Insulinoma

Keywords

  • Hypoglycemia
  • Insulinoma
  • Natural History
03

In context

Hypoglycemia

706 studies on the registry are indexed under Hypoglycemia; 94 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 86 across 131 observational studies indexed under Hypoglycemia.

Browse Hypoglycemia studies →

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is the lead sponsor of 538 studies on the registry; 55 are open to participants now.

Of its 80 completed or terminated interventional studies of FDA-regulated products, 51 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients how are referred to us that have fasting hypoglycemia due to diverse etiologies.@@@@@@

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,500 participants (estimated)

Groups and cohorts

  • Patients with hypoglycemia

    Patients with hypoglycemia due to diverse etiologies.

06

What researchers measure

Primary outcomes

  1. Treatment Outcomes

    resolution of hypoglycemia

    Time frame: every 1-3 months

07

Study locations

1 of 1 sites recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    Recruiting
08

References and documents

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. PubMed 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. PubMed 6349454 ↗
  • Comi RJ, Gorden P. Approach to hypoglycemia in adults. Compr Ther. 1987 Mar;13(3):38-44. No abstract available. PubMed 3568598 ↗

Individual participant data

Plan to share: No

09

Timeline

7 registry updates since Sep 25, 2026

Started May 1991 (actual).

How these figures are worked out, and which studies are left out of them.

Registered
Nov 3, 1999
First posted
Nov 4, 1999
StartActual
May 21, 1991
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Contact
Study contact changed: c•••@bdg10.niddk.nih.gov · •••1880→m•••@nih.gov · •••8137. See the current contact
Oct 20, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • National Institutes of Health Clinical Center · Bethesda, United StatesContact added m•••@nih.gov · •••8137
Oct 20, 2026
Show all 7 updates
  1. Oct 20, 2026
    Contact Study contact changed: c•••@bdg10.niddk.nih.gov · •••1880→m•••@nih.gov · •••8137. See the current contact
    Site contacts Changed at 1 site. See the sites
    Show the site
    • National Institutes of Health Clinical Center · Bethesda, United StatesContact added m•••@nih.gov · •••8137
    + 1 other change: verification date
  2. Oct 13, 2026
    Minor edits only
    + 1 other change: description
  3. Oct 8, 2026
    Minor edits only
    + 1 other change: description
  4. Oct 7, 2026
    Minor edits only
    + 1 other change: verification date
  5. Oct 5, 2026
    Minor edits only
    + 1 other change: verification date
  6. Oct 2, 2026
    Minor edits only
    + 1 other change: description
  7. Sep 28, 2026
    Minor edits only
    + 1 other change: description

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT00001276
Responsible party
Sponsor
First posted
Nov 4, 1999
Start date
May 21, 1991
Last update
Oct 20, 2026

Study contacts

Magaly R Donayre
Contact
magaly.donayre@nih.gov
(202) 909-8137
Ranganath Muniyappa, M.D.
Contact
muniyapr@mail.nih.gov
(301) 451-7702
Ranganath Muniyappa, M.D.
principal investigator · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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