Trial Outcomes & Findings for Hydroxychloroquine and Metabolic Outcomes in Patients Undergoing TPAIT (NCT NCT03283566)
NCT ID: NCT03283566
Last Updated: 2022-04-08
Results Overview
HCQ-treated compared to placebo arm. This outcome measure was reported in Mean and Standard deviation looking at C peptide/glucose secretion at 90 mins during mixed meal test adjusted for IEG/Kg (islet cell equivalency) infused to the patient.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
12 months
Results posted on
2022-04-08
Participant Flow
Participant milestones
| Measure |
Hydroxychloroquine
Administered pre-transplant through 3 months after surgery.
Hydroxychloroquine: Subjects will receive a pre-transplant 200 mg daily dose of HCQ 30 days before TPAIT and will continue on the drug for 3 months after surgery.
|
Placebo
Placebo treatment following the same schedule as Arm 1 (i.e. Hydroxychloroquine).
Placebo: Subjects will receive a pre-transplant placebo 30 days before TPAIT and will continue on the placebo for 3 months after surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Hydroxychloroquine
Administered pre-transplant through 3 months after surgery.
Hydroxychloroquine: Subjects will receive a pre-transplant 200 mg daily dose of HCQ 30 days before TPAIT and will continue on the drug for 3 months after surgery.
|
Placebo
Placebo treatment following the same schedule as Arm 1 (i.e. Hydroxychloroquine).
Placebo: Subjects will receive a pre-transplant placebo 30 days before TPAIT and will continue on the placebo for 3 months after surgery.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Hydroxychloroquine
n=3 Participants
Administered pre-transplant through 3 months after surgery.
Hydroxychloroquine: Subjects will receive a pre-transplant 200 mg daily dose of HCQ 30 days before TPAIT and will continue on the drug for 3 months after surgery.
|
Placebo
n=3 Participants
Placebo treatment following the same schedule as Arm 1 (i.e. Hydroxychloroquine).
Placebo: Subjects will receive a pre-transplant placebo 30 days before TPAIT and will continue on the placebo for 3 months after surgery.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 12 • n=3 Participants
|
37 years
STANDARD_DEVIATION 3 • n=3 Participants
|
43.5 years
STANDARD_DEVIATION 7.5 • n=6 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: C-peptide/Glucose = ng/mg glucose/IEQ/kg - Primary 12-month endpoint
HCQ-treated compared to placebo arm. This outcome measure was reported in Mean and Standard deviation looking at C peptide/glucose secretion at 90 mins during mixed meal test adjusted for IEG/Kg (islet cell equivalency) infused to the patient.
Outcome measures
| Measure |
Hydroxychloroquine
n=3 Participants
Administered pre-transplant through 3 months after surgery.
Hydroxychloroquine: Subjects will receive a pre-transplant 200 mg daily dose of HCQ 30 days before TPAIT and will continue on the drug for 3 months after surgery.
|
Placebo
n=3 Participants
Placebo treatment following the same schedule as Arm 1 (i.e. Hydroxychloroquine).
Placebo: Subjects will receive a pre-transplant placebo 30 days before TPAIT and will continue on the placebo for 3 months after surgery.
|
|---|---|---|
|
Quotient of Stimulated C-peptide/Glucose Level Normalized for IEQ/Kg Infused in Response to MMTT
|
.000000077 ng/mg glucose/IEQ/kg
Standard Deviation .000000096
|
0.000000079 ng/mg glucose/IEQ/kg
Standard Deviation .00000012
|
SECONDARY outcome
Timeframe: 12 monthsHCQ-treated compared to placebo arm. We used a standard, 5 hour Mixed meal tolerance test (MMT). Blood draws were taken every 15 mins for the first hours, then every 30 mins the second hour, then hourly until completion.
Outcome measures
| Measure |
Hydroxychloroquine
n=3 Participants
Administered pre-transplant through 3 months after surgery.
Hydroxychloroquine: Subjects will receive a pre-transplant 200 mg daily dose of HCQ 30 days before TPAIT and will continue on the drug for 3 months after surgery.
|
Placebo
n=3 Participants
Placebo treatment following the same schedule as Arm 1 (i.e. Hydroxychloroquine).
Placebo: Subjects will receive a pre-transplant placebo 30 days before TPAIT and will continue on the placebo for 3 months after surgery.
|
|---|---|---|
|
C-peptide AUC Response to MMTT
|
813 ng/mL/min
Standard Deviation 463
|
588 ng/mL/min
Standard Deviation 391
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Treatment versus placebo
C-peptide, ng/mL/min/IEQ/kg iAUC post-MMTT. Our measurement can be reported in area under the curve for C-peptide normalized for glucose values as well as Islet cell mass infused to the patient in order to compare placebo vs intervention arms.
Outcome measures
| Measure |
Hydroxychloroquine
n=3 Participants
Administered pre-transplant through 3 months after surgery.
Hydroxychloroquine: Subjects will receive a pre-transplant 200 mg daily dose of HCQ 30 days before TPAIT and will continue on the drug for 3 months after surgery.
|
Placebo
n=3 Participants
Placebo treatment following the same schedule as Arm 1 (i.e. Hydroxychloroquine).
Placebo: Subjects will receive a pre-transplant placebo 30 days before TPAIT and will continue on the placebo for 3 months after surgery.
|
|---|---|---|
|
Ratio of C-peptide AUC to Glucose AUC in Response to MMTT Adjusted for Infused Islet Cell Mass
|
0.00091 ng/mL/min/IEQ/kg iAUC post-MMT
Standard Deviation 0.0006
|
0.00222 ng/mL/min/IEQ/kg iAUC post-MMT
Standard Deviation 0.0029
|
Adverse Events
Hydroxychloroquine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
EMI Research Director
Cleveland Clinic Foundation, Department of Endocroine and Metabolism
Phone: 216 445-3757
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place