Clinical trial NCT05716607: Treatment Study in Patients Treated With Both Insulin & Hydrocortisone
Official title: Randomized Cross-over Trial in Patients Treated With Both Insulin & Hydrocortisone
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Adrenal Insufficiency
Polyglandular Autoimmune Syndrome
Keywords: Insulin treatment
Hydrocortisone treatment
Opposing effects on glucose metabolism
Randomized Controlled Trial
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
Collaborators: name: The Swedish Society of Medicine
name: Åke Wibergs Stiftelse
name: Sahlgrenska University Hospital
name: Pilloxa
First posted: 2023-02-08
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Single-center, randomized, open-label, two-period cross-over trial
Primary purpose: TREATMENT

Brief summary: The aim of INS.CORT trial is, by studying glycemic variability in a well-defined patient group with both insulin \& hydrocortisone (patients with concomitant insulin-treated diabetes \& Addison's disease) and collecting information about the administration -time point and doses- of insulin, hydrocortisone and food intake with the help of new technology to improve the treatment in all patients treated with both insulin \& glucocorticoids.


Eligibility criteria: Inclusion Criteria:

Men and women at age 18 to 70 years, with BMI 18-32 kg/m2 and well-defined both insulin-treated diabetes \& Addison's disease for \>12 months each, on insulin treatment and stable hydrocortisone replacement with once-daily dual-release hydrocortisone (20-30 mg/day) for \>3 months.

Exclusion Criteria:

* Any medication with other glucose lowering agents than insulin
* Any additional underlying or intercurrent disease that may need regular or periodic pharmacological treatment with glucocorticoids during the study period, including infectious diseases
* Any medication with agents which in the investigator's judgement might interfere with the study drugs kinetics, including therapies affecting gastrointestinal emptying or motility
* Any medication with oral estrogen supplementation and/or regular DHEA medication for the past 4 weeks
* Clinically significant renal dysfunction with a serum creatinine above 160 mmol/L
* Active malignancy
* Clinical or laboratory signs of significant cerebral, cardiovascular, respiratory, hepatobiliary/pancreatic disease which in the investigator's judgement may interfere with the study assessment
* Pregnant or lactating women
* Alcohol/drug abuse or any other condition associated with poor patient compliance, including expected non-cooperation, as judged by the investigator.

Primary outcomes:
measure: glycemic variability
timeFrame: 4 weeks
Secondary outcomes:
measure: HbA1c
timeFrame: 4 weeks
measure: Time in range (glucose)
timeFrame: 4 weeks
measure: Time above range (glucose)
timeFrame: 4 weeks
measure: Time below range (glucose)
timeFrame: 4 weeks
measure: Cortisol exposure-time profile
timeFrame: 4 weeks
measure: systolic blood pressure
timeFrame: 4 weeks
measure: diastolic blood pressure
timeFrame: 4 weeks
measure: ADDIQoL
timeFrame: 4 weeks
measure: PGWB
timeFrame: 4 weeks
measure: FIS
timeFrame: 4 weeks
measure: FOSQ
timeFrame: 4 weeks
measure: Fever
timeFrame: 4 weeks
measure: CD16
timeFrame: 4 weeks
measure: ADAM17
timeFrame: 4 weeks
measure: transcriptomics
timeFrame: 4 weeks
measure: microRNAs
timeFrame: 4 weeks
measure: proteomics
timeFrame: 4 weeks
measure: metabolomics
timeFrame: 4 weeks
measure: hsCRP fibrinogen, immunoglobulin
timeFrame: 4 weeks
measure: SR
timeFrame: 4 weeks
measure: fibrinogen
timeFrame: 4 weeks
measure: immunoglobulins
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Sahlgrenska University Hospital
name: Dimitrios Chantzichristos, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: