Trial Outcomes & Findings for Thyroid Hormone to Induce Non-Insulin Mediated Glucose Disposal in People With Insulin Receptor Mutations (NCT NCT02457897)

NCT ID: NCT02457897

Last Updated: 2019-12-05

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 7 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2019-12-05

Participant Flow

Participant milestones

Measure	Patients With Insulin Receptor Mutation Liothyronine: Oral supplement given every 8 hours
Part 1 Short-term (2 Weeks) Study STARTED	7
Part 1 Short-term (2 Weeks) Study COMPLETED	7
Part 1 Short-term (2 Weeks) Study NOT COMPLETED	0
Part 2 Long-term (6 Month) Study STARTED	5
Part 2 Long-term (6 Month) Study COMPLETED	5
Part 2 Long-term (6 Month) Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Thyroid Hormone to Induce Non-Insulin Mediated Glucose Disposal in People With Insulin Receptor Mutations

Baseline characteristics by cohort

Measure	Patients With Insulin Receptor Mutation n=7 Participants Liothyronine: Oral supplement given every 8 hours
Age, Continuous	22 years STANDARD_DEVIATION 5.92 • n=93 Participants
Sex: Female, Male Female	3 Participants n=93 Participants
Sex: Female, Male Male	4 Participants n=93 Participants
Race/Ethnicity, Customized Asian	3 Participants n=93 Participants
Race/Ethnicity, Customized Black	2 Participants n=93 Participants
Race/Ethnicity, Customized White	2 Participants n=93 Participants
Body Mass Index	19.84 kg/m^2 STANDARD_DEVIATION 8.33 • n=93 Participants

PRIMARY outcome

Timeframe: 2 weeks

Outcome measures

Measure	Patients With Insulin Receptor Mutation n=7 Participants Liothyronine: Oral supplement given every 8 hours
Total Body Glucose Disposal in the Fasting State	21.47 μmol/kg LBM (Lean Body Mass)/min Standard Deviation 6

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Measure	Patients With Insulin Receptor Mutation n=5 Participants Liothyronine: Oral supplement given every 8 hours
Hemoglobin A1C	9.1 percentage of glycosylated hemoglobin Standard Deviation 3

SECONDARY outcome

Timeframe: 2 weeks

Outcome measures

Measure	Patients With Insulin Receptor Mutation n=5 Participants Liothyronine: Oral supplement given every 8 hours
Muscle Glucose Uptake	0.9 μmol/min/100ml Standard Deviation 0.08

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	Patients With Insulin Receptor Mutation n=2 Participants Liothyronine: Oral supplement given every 8 hours
Muscle Glucose Uptake	2.0 μmol/min/100ml Standard Deviation 0.2

Adverse Events

Patients With Insulin Receptor Mutation

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Patients With Insulin Receptor Mutation n=7 participants at risk Liothyronine: Oral supplement given every 8 hours
Immune system disorders Allergic reaction (after eating Indian food)	14.3% 1/7 • Number of events 1 • 6 months
Respiratory, thoracic and mediastinal disorders Upper Respiratory infection	14.3% 1/7 • Number of events 1 • 6 months
Endocrine disorders Hyperglycemia	14.3% 1/7 • Number of events 1 • 6 months

Additional Information

Dr. Rebecca Brown

NIDDK

Phone: 301-594-0609

Email: Rebecca.Brown@NIH.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place