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Trial Outcomes & Findings for Insulin Sensitivity in Patients With Atopic Dermatitis (NCT NCT03003793)

NCT ID: NCT03003793

Last Updated: 2019-10-18

Results Overview

The outcome is determined by measuring the glucose necessary to maintain euglycaemia during increased insulin levels generated by continuous insulin infusion (measured as the M-value: the rate of glucose infused is equal to the rate of whole-body glucose disposal or metabolizable glucose (M) and reflects the amount of exogenous glucose necessary to fully compensate for the hyperinsulinemia)

Recruitment status

COMPLETED

Target enrollment

32 participants

Primary outcome timeframe

Baseline, plasma glucose every 5 minutes, insulin/C-peptide, glucagon every 10-15 minutes throughout a 3 hour hyperinsulinaemic euglycaemic clamp

Results posted on

2019-10-18

Participant Flow

Participant milestones

Participant milestones
Measure
Control Group
Healthy control subjects Hyperinsulinemic euglycemic clamp
Atopic Dermatitis/Eczema Group
Patients with atopic dermatitis Hyperinsulinemic euglycemic clamp
Overall Study
STARTED
16
16
Overall Study
COMPLETED
16
16
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Insulin Sensitivity in Patients With Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Control Group
n=16 Participants
Healthy control subjects Hyperinsulinemic euglycemic clamp
Atopic Dermatitis/Eczema Group
n=16 Participants
Patients with atopic dermatitis Hyperinsulinemic euglycemic clamp
Total
n=32 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
16 Participants
n=5 Participants
16 Participants
n=7 Participants
32 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Continuous
33 years
STANDARD_DEVIATION 3 • n=5 Participants
33 years
STANDARD_DEVIATION 3 • n=7 Participants
33 years
STANDARD_DEVIATION 3 • n=5 Participants
Sex: Female, Male
Female
9 Participants
n=5 Participants
9 Participants
n=7 Participants
18 Participants
n=5 Participants
Sex: Female, Male
Male
7 Participants
n=5 Participants
7 Participants
n=7 Participants
14 Participants
n=5 Participants
Region of Enrollment
Denmark
16 participants
n=5 Participants
16 participants
n=7 Participants
32 participants
n=5 Participants
Atopic dermatitis duration
NA years
STANDARD_DEVIATION NA • n=5 Participants
28 years
STANDARD_DEVIATION 3 • n=7 Participants
NA years
STANDARD_DEVIATION NA • n=5 Participants
Body master index
24.4 kg/m^2
STANDARD_DEVIATION 1 • n=5 Participants
24.5 kg/m^2
STANDARD_DEVIATION 1 • n=7 Participants
24.5 kg/m^2
STANDARD_DEVIATION 1 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, plasma glucose every 5 minutes, insulin/C-peptide, glucagon every 10-15 minutes throughout a 3 hour hyperinsulinaemic euglycaemic clamp

The outcome is determined by measuring the glucose necessary to maintain euglycaemia during increased insulin levels generated by continuous insulin infusion (measured as the M-value: the rate of glucose infused is equal to the rate of whole-body glucose disposal or metabolizable glucose (M) and reflects the amount of exogenous glucose necessary to fully compensate for the hyperinsulinemia)

Outcome measures

Outcome measures
Measure
Control Group
n=16 Participants
Healthy control subjects Hyperinsulinemic euglycemic clamp
Atopic Dermatitis/Eczema Group
n=16 Participants
Patients with atopic dermatitis Hyperinsulinemic euglycemic clamp
Insulin Sensitivity Difference Between Patients With Atopic Dermatitis and Controls
9.8 mg glucose/kg body mass/minute
Standard Deviation 0.8
9.2 mg glucose/kg body mass/minute
Standard Deviation 0.6

Adverse Events

Control Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Atopic Dermatitis/Eczema Group

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

Lise Gether, MD

Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen

Results disclosure agreements

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