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NCT02457897 · ClinicalTrials.gov registry record · Phase 2
Thyroid Hormone to Induce Non-Insulin Mediated Glucose Disposal in People With Insulin Receptor Mutations
A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT02457897 is a Phase 2 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 7 participants.
The verdict
NCT02457897, a Phase 2 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study Summary
Background: \- Insulin receptor mutation causes high blood sugars and sometimes diabetes complications. Researchers want to see if thyroid hormone helps. Objectives: \- To see if thyroid hormone treatment changes how the body handles sugar in people with insulin receptor mutation and improves blood sugar in people with diabetes. Eligibility: \- People ages 12 65 with an insulin receptor mutation. Design: * Study part 1:19-day clinic stay. Participants will be monitored for 4 days. Then for 15 days they will take a thyroid hormone pill 3 times a day. Participants will have: * Blood tests. * Heart rate and skin temperature monitored. * All their food provided. * Two 5-hour sessions in a special room. They will wear special clothes and sometimes sit still. * Two small tubes inserted in veins. One will deliver tiny amounts of sugar and fat with a non-radioactive tracer. Participants will also drink water with a tracer. The other tube will collect blood. * A sweet drink. Participants may have finger stick blood sugar tests. * Glucose-monitoring device inserted into body fat for two 24-hour periods. * Adults may have samples of fat and muscle taken. * Heart ultrasound. * PET-CT scan in a machine. An intravenous catheter will be placed in an arm vein. A small amount of radioactive substance will be injected. * DEXA scan of body fat and bone density. * Participants with poorly controlled diabetes will then take thyroid hormone at home for 6 months. They will have blood drawn and sent to the study team monthly. * After about 3 months, they will have an overnight visit. After 6 months, they will have a 4-day visit.
Interventions
- DRUG Liothyronine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2015-04-17 |
| Est. Completion | 2018-09-18 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02457897
The ClinicalTrials.gov registry entry for NCT02457897 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Liothyronine is the first listed.
NCT02457897 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02457897 about?
NCT02457897 is a clinical study titled "Thyroid Hormone to Induce Non-Insulin Mediated Glucose Disposal in People With Insulin Receptor Mutations". Background: \- Insulin receptor mutation causes high blood sugars and sometimes diabetes complications. Researchers want to see if thyroid hormone helps. Objectives: \- To see if thyroid hormone treatment changes how the body handles sugar in people with insulin receptor mutation and improves blo...
What is the current status of trial NCT02457897?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2015-04-17. Estimated completion is 2018-09-18.
What interventions are being tested in trial NCT02457897?
The interventions under investigation include: Liothyronine (DRUG).
Who is sponsoring clinical trial NCT02457897?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
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