Treatment Study in Patients Treated With Both Insulin & Hydrocortisone

Diabetes Mellitus Clinical Trial

— INSCORT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05716607
• Other study ID #: INS.CORT
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: December 2027

Study information

• Verified date: April 2024
• Source: Vastra Gotaland Region
• Contact: Dimitrios Chantzichristos, MD PhD
• Phone: +46313428547
• Email: dimitrios.chantzichristos[@]gu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: December 2027
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adrenal Insufficiency
• Diabetes Mellitus
• Polyendocrinopathies, Autoimmune

Intervention

Drug:
• OD dual-release Hydrocortisone
Treatment with once-daily dual-release hydrocortisone
• TID Hydrocortisone
Treatment with thrice-daily conventional immediate-release hydrocortisone

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg

Sponsors (5)

Lead Sponsor	Collaborator
Vastra Gotaland Region	Åke Wibergs Stiftelse, Pilloxa, Sahlgrenska University Hospital, Sweden, The Gothenburg Society of Medicine

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glycemic variability	glycemic variability	4 weeks
Secondary	HbA1c	HbA1c	4 weeks
Secondary	Time in range (glucose)	Time in range (glucose)	4 weeks
Secondary	Time above range (glucose)	Time above range (glucose)	4 weeks
Secondary	Time below range (glucose)	Time below range (glucose)	4 weeks
Secondary	Cortisol exposure-time profile	Cortisol exposure-time profile	4 weeks
Secondary	systolic blood pressure	systolic blood pressure in sitting position	4 weeks
Secondary	diastolic blood pressure	diastolic blood pressure in sitting position	4 weeks
Secondary	ADDIQoL	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.	4 weeks
Secondary	PGWB	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.	4 weeks
Secondary	FIS	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.	4 weeks
Secondary	FOSQ	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.	4 weeks
Secondary	Fever	Incidence of infections with high fever (patients judgement)	4 weeks
Secondary	CD16	immunophenotyping of peripheral blood mononuclear cells (PBMCs) with measurement of soluble CD16	4 weeks
Secondary	ADAM17	immunophenotyping of peripheral blood mononuclear cells (PBMCs) with measurement of soluble ADAM17	4 weeks
Secondary	transcriptomics	RNA sequencing for large-scale study of gene expression in circulation	4 weeks
Secondary	microRNAs	large-scale study of microRNAs in circulation	4 weeks
Secondary	proteomics	large-scale study of proteomes (proteins produced in study subjects)	4 weeks
Secondary	metabolomics	large-scale study of metabolome (metabolites produced in study subjects)	4 weeks
Secondary	hsCRP fibrinogen, immunoglobulin	High-sensitivity C-reactive Protein (laboratory measurement)	4 weeks
Secondary	SR	erythrocyte sedimentation rate (laboratory measurement)	4 weeks
Secondary	fibrinogen	fibrinogen (laboratory measurement)	4 weeks
Secondary	immunoglobulins	immunoglobulin levels in fem klasser: IgA, IgD, IgE, IgG och IgM	4 weeks