Treatment Study in Patients Treated With Both Insulin & Hydrocortisone

N/ANot Yet RecruitingNCT05716607

Vastra Gotaland Region16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus Adrenal Insufficiency Polyglandular Autoimmune Syndrome

Interventions

OD dual-release HydrocortisoneDRUG

Treatment with once-daily dual-release hydrocortisone

TID HydrocortisoneDRUG

Treatment with thrice-daily conventional immediate-release hydrocortisone

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sahlgrenska University Hospital

Gothenburg, Sweden

Outcomes

Primary Outcomes

glycemic variability

Time frame: 4 weeks

Secondary Outcomes

HbA1c

Time frame: 4 weeks

Time in range (glucose)

Time frame: 4 weeks

Time above range (glucose)

Time frame: 4 weeks

Time below range (glucose)

Time frame: 4 weeks

Cortisol exposure-time profile

Time frame: 4 weeks

systolic blood pressure

systolic blood pressure in sitting position

Time frame: 4 weeks

diastolic blood pressure

diastolic blood pressure in sitting position

Time frame: 4 weeks

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.

Central Contacts

Dimitrios Chantzichristos, MD PhD

CONTACT

+46313428547 dimitrios.chantzichristos@gu.se

Data from ClinicalTrials.gov

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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.

Time frame: 4 weeks

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.

Time frame: 4 weeks

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.

Time frame: 4 weeks

Fever

Incidence of infections with high fever (patients judgement)

Time frame: 4 weeks

CD16

immunophenotyping of peripheral blood mononuclear cells (PBMCs) with measurement of soluble CD16

Time frame: 4 weeks

ADAM17

immunophenotyping of peripheral blood mononuclear cells (PBMCs) with measurement of soluble ADAM17

Time frame: 4 weeks

transcriptomics

RNA sequencing for large-scale study of gene expression in circulation

Time frame: 4 weeks

microRNAs

large-scale study of microRNAs in circulation

Time frame: 4 weeks

proteomics

large-scale study of proteomes (proteins produced in study subjects)

Time frame: 4 weeks

metabolomics

large-scale study of metabolome (metabolites produced in study subjects)

Time frame: 4 weeks

hsCRP fibrinogen, immunoglobulin

High-sensitivity C-reactive Protein (laboratory measurement)

Time frame: 4 weeks

erythrocyte sedimentation rate (laboratory measurement)

Time frame: 4 weeks

fibrinogen

fibrinogen (laboratory measurement)

Time frame: 4 weeks

immunoglobulins

immunoglobulin levels in fem klasser: IgA, IgD, IgE, IgG och IgM

Time frame: 4 weeks