Treatment Study in Patients Treated With Both Insulin & Hydrocortisone

Not Applicable

Not yet recruiting

• Conditions: Diabetes Mellitus; Adrenal Insufficiency; Polyglandular Autoimmune Syndrome
• Interventions: Drug: TID Hydrocortisone; Drug: OD dual-release Hydrocortisone

• Registration Number: NCT05716607
• Lead Sponsor: Vastra Gotaland Region

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-18
• Study First Submitted QC: 2023-01-27
• Study First Posted: 2023-02-08
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-28
• Last Update Posted: 2024-04-30
• Study Start: 2024-09
• Primary Completion: 2025-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Thrice-daily conventional immediate-release hydrocortisone	TID Hydrocortisone	-
Once-daily dual-release hydrocortisone	OD dual-release Hydrocortisone	-

Primary Outcome Measures

Name	Time	Method
glycemic variability	4 weeks	glycemic variability

Secondary Outcome Measures

Name	Time	Method
Time below range (glucose)	4 weeks	Time below range (glucose)
immunoglobulins	4 weeks	immunoglobulin levels in fem klasser: IgA, IgD, IgE, IgG och IgM
Time in range (glucose)	4 weeks	Time in 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.
SR	4 weeks	erythrocyte sedimentation rate (laboratory measurement)
fibrinogen	4 weeks	fibrinogen (laboratory measurement)
HbA1c	4 weeks	HbA1c
Time above range (glucose)	4 weeks	Time above range (glucose)
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.
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)
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

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden