AD-IF: Insulin Sensitivity in Patients With Atopic Dermatitis

• Sponsor: University Hospital, Gentofte, Copenhagen (Other)
• Overall Status: Completed
• CT.gov ID: NCT03003793
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Actual Duration (Months): 25
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

The incidence of atopic dermatitis and type 2 diabetes, respectively, has increased over many years. Novel research shows an association between the two conditions. While this relationship at least in theory can be explained by lifestyle factors, there is reason to believe that other pathophysiological mechanisms are involved. Hence, our hypothesis is that patients with atopic dermatitis are insulin resistant due to their chronic inflammatory state. Insulin resistance might play an unknown part in the increased frequency of type 2 diabetes among patients with atopic dermatitis. In the present project, the investigators aim to measure insulin sensitivity by means of the 'golden standard' hyperinsulinaemic euglycaemic clamp in patients suffering from atopic dermatitis compared to a healthy control group (matched case-control study). The project is a close collaboration between The Department of Dermatology and Allergy and Center for Diabetes Research at Gentofte Hospital.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis/Eczema; Type 2 Diabetes	Diagnostic Test: Hyperinsulinemic euglycemic clamp

Study Design

• Study Type: Observational
• Actual Enrollment: 32 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Insulin Sensitivity in Patients With Atopic Dermatitis
• Actual Study Start Date: Nov 1, 2015
• Actual Primary Completion Date: Sep 1, 2016
• Actual Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Control group Healthy control subjects	Diagnostic Test: Hyperinsulinemic euglycemic clamp; Hyperinsulinemic euglycemic clamp to detect insulin sensitivity
Atopic dermatitis/eczema group Patients with atopic dermatitis	Diagnostic Test: Hyperinsulinemic euglycemic clamp; Hyperinsulinemic euglycemic clamp to detect insulin sensitivity

Outcome Measures

Primary Outcome Measures

1. Insulin Sensitivity Difference Between Patients With Atopic Dermatitis and Controls [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Moderate to severe atopic dermatitis for at least 5 years

• BMI < 30 kg/m2

• HbA1c < 42 mmol/mol

Exclusion Criteria:

• Diabetes

• Prediabetes

• First-degree relatives with diabetes

• Chronic inflammatory diseases other than atopic dermatitis and asthma

• Pregnancy

• Breast-feeding

• Daily intake of medications that are known to influence the glucose metabolism are not allowed one month before the study (e.g. asthma medicines and hormonal contraception).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Diabetes Research, Gentofte Hospital, University of Copenhagen	Hellerup		Denmark	2900

Sponsors and Collaborators

• University Hospital, Gentofte, Copenhagen

Investigators

• Study Director: Filip K Knop, MD, PhD, University Hospital, Gentofte
• Study Director: Jacob P Thyssen, MD,PhD,DMSc, University Hospital, Gentofte

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Filip Krag Knop, MD PhD, University Hospital, Gentofte, Copenhagen
• ClinicalTrials.gov Identifier: NCT03003793
• Other Study ID Numbers: H-15010198
• First Posted: Dec 28, 2016
• Last Update Posted: Oct 18, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema; Insulin Resistance

Study Results

Participant Flow

Arm/Group Title	Control Group	Atopic Dermatitis/Eczema Group
Arm/Group Description	Healthy control subjects Hyperinsulinemic euglycemic clamp	Patients with atopic dermatitis Hyperinsulinemic euglycemic clamp
Period Title: Overall Study
STARTED	16	16
COMPLETED	16	16
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Control Group	Atopic Dermatitis/Eczema Group	Total
Arm/Group Description	Healthy control subjects Hyperinsulinemic euglycemic clamp	Patients with atopic dermatitis Hyperinsulinemic euglycemic clamp	Total of all reporting groups
Overall Participants	16	16	32
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	16 100%	16 100%	32 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33 (3)	33 (3)	33 (3)
Sex: Female, Male (Count of Participants)
Female	9 56.3%	9 56.3%	18 56.3%
Male	7 43.8%	7 43.8%	14 43.8%
Region of Enrollment (participants) [Number]
Denmark	16 100%	16 100%	32 100%
Atopic dermatitis duration (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	NA (NA)	28 (3)	NA (NA)
Body master index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	24.4 (1)	24.5 (1)	24.5 (1)

Outcome Measures

1. Primary Outcome

Title	Insulin Sensitivity Difference Between Patients With Atopic Dermatitis and Controls
Description	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)
Time Frame	Baseline, plasma glucose every 5 minutes, insulin/C-peptide, glucagon every 10-15 minutes throughout a 3 hour hyperinsulinaemic euglycaemic clamp

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Atopic Dermatitis/Eczema Group
Arm/Group Description	Healthy control subjects Hyperinsulinemic euglycemic clamp	Patients with atopic dermatitis Hyperinsulinemic euglycemic clamp
Measure Participants	16	16
Mean (Standard Deviation) [mg glucose/kg body mass/minute]	9.8 (0.8)	9.2 (0.6)

Adverse Events

Arm/Group Title	Control Group		Atopic Dermatitis/Eczema Group
Arm/Group Description	Healthy control subjects Hyperinsulinemic euglycemic clamp		Patients with atopic dermatitis Hyperinsulinemic euglycemic clamp
All Cause Mortality
	Control Group		Atopic Dermatitis/Eczema Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Control Group		Atopic Dermatitis/Eczema Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/16 (0%)
Other (Not Including Serious) Adverse Events
	Control Group		Atopic Dermatitis/Eczema Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/16 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.