Thyroid Hormone to Induce Non-Insulin Mediated Glucose Disposal in People With Insulin Receptor Mutations
Status:
Completed
Trial end date:
2018-09-18
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)