INSCORT: Treatment Study in Patients Treated With Both Insulin & Hydrocortisone

Sponsor

Vastra Gotaland Region (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05716607

Collaborator

The Gothenburg Society of Medicine (Other), Åke Wibergs Stiftelse (Other), Sahlgrenska University Hospital, Sweden (Other), Pilloxa (Industry)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus Adrenal Insufficiency Polyglandular Autoimmune Syndrome	Drug: OD dual-release Hydrocortisone Drug: TID Hydrocortisone	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Single-center, randomized, open-label, two-period cross-over trialSingle-center, randomized, open-label, two-period cross-over trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Randomized Cross-over Trial in Patients Treated With Both Insulin & Hydrocortisone

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Once-daily dual-release hydrocortisone	Drug: OD dual-release Hydrocortisone Treatment with once-daily dual-release hydrocortisone Other Names: Once-daily dual-release hydrocortisone
Active Comparator: Thrice-daily conventional immediate-release hydrocortisone	Drug: TID Hydrocortisone Treatment with thrice-daily conventional immediate-release hydrocortisone Other Names: Thrice-daily conventional immediate-release hydrocortisone

Arm

Intervention/Treatment

Experimental: Once-daily dual-release hydrocortisone

Drug: OD dual-release Hydrocortisone

Treatment with once-daily dual-release hydrocortisone

Other Names:

Once-daily dual-release hydrocortisone

Active Comparator: Thrice-daily conventional immediate-release hydrocortisone

Drug: TID Hydrocortisone

Treatment with thrice-daily conventional immediate-release hydrocortisone

Other Names:

Thrice-daily conventional immediate-release hydrocortisone

Outcome Measures

Primary Outcome Measures

glycemic variability [4 weeks]
glycemic variability

Secondary Outcome Measures

HbA1c [4 weeks]
HbA1c
Time in range (glucose) [4 weeks]
Time in range (glucose)
Time above range (glucose) [4 weeks]
Time above range (glucose)
Time below range (glucose) [4 weeks]
Time below range (glucose)
Cortisol exposure-time profile [4 weeks]
Cortisol exposure-time profile
systolic blood pressure [4 weeks]
systolic blood pressure in sitting position
diastolic blood pressure [4 weeks]
diastolic blood pressure in sitting position
ADDIQoL [4 weeks]
questionnaire: the Addison-specific quality-of-life (ADDIQoL) The AddiQoL is a 36-item questionnaire; each item contains six scoring categories. Twenty-five items are negative Health-Related Quality of Life (HRQoL) statements that need to be reversed for questionnaire scoring; thus, a higher score indicates a higher level of HRQoL.
PGWB [4 weeks]
questionnaire: the Psychological General Well-Being (PGWB) index The Psychological General Well-Being Index (PGWBI) is a measure of the level of subjective psychological well-being. In detail, it assesses self-representations of intrapersonal affective or emotional states reflecting a sense of subjective well-being or distress and thus captures what we could call a subjective perception of well-being. Consisting of 22 standardized items (6 items for the short form), the tool produces a single measure of psychological well-being. The full measure also provides sub-scales to assess the following domains: anxiety, depression, positive well-being, self-control, general health, and vitality.
FIS [4 weeks]
questionnaire: the Fatigue Impact Scale (FIS) The FIS was developed to assess the symptom of fatigue as part of an underlying chronic disease or condition. Consisting of 40 items, the instrument evaluates the effect of fatigue on three domains of daily life: cognitive functioning, physical functioning, and psychosocial functioning minimum and maximum values, and whether higher scores mean a better or worse outcome. Higher scores mean a worse outcome. Min 0 points, max 160 points.
FOSQ [4 weeks]
questionnaire: the Functional Outcomes of Sleep Questionnaire (FOSQ) Disease specific quality of life questionnaire to determine functional status in adults; measures are designed to assess the impact of disorders of excessive sleepiness on multiple activities of everyday living and the extent to which these abilities are improved by effective treatment. Name of categories assessed: Activity level, vigilance, intimacy and sexual relationships, general productivity, social outcome, rate the difficulty of performing a given activity on a 4-point scale (no difficulty to extreme difficulty). Higher scores mean a better outcome. Min 0 points, max 120 points.
Fever [4 weeks]
Incidence of infections with high fever (patients judgement)
CD16 [4 weeks]
immunophenotyping of peripheral blood mononuclear cells (PBMCs) with measurement of soluble CD16
ADAM17 [4 weeks]
immunophenotyping of peripheral blood mononuclear cells (PBMCs) with measurement of soluble ADAM17
transcriptomics [4 weeks]
RNA sequencing for large-scale study of gene expression in circulation
microRNAs [4 weeks]
large-scale study of microRNAs in circulation
proteomics [4 weeks]
large-scale study of proteomes (proteins produced in study subjects)
metabolomics [4 weeks]
large-scale study of metabolome (metabolites produced in study subjects)
hsCRP fibrinogen, immunoglobulin [4 weeks]
High-sensitivity C-reactive Protein (laboratory measurement)
SR [4 weeks]
erythrocyte sedimentation rate (laboratory measurement)
fibrinogen [4 weeks]
fibrinogen (laboratory measurement)
immunoglobulins [4 weeks]
immunoglobulin levels in fem klasser: IgA, IgD, IgE, IgG och IgM

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.