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Treatment Study in Patients Treated With Both Insulin & Hydrocortisone (INSCORT)

Primary Purpose

Diabetes Mellitus, Adrenal Insufficiency, Polyglandular Autoimmune Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
OD dual-release Hydrocortisone
TID Hydrocortisone
Sponsored by
Vastra Gotaland Region
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Insulin treatment, Hydrocortisone treatment, Opposing effects on glucose metabolism, Randomized Controlled Trial

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Once-daily dual-release hydrocortisone

Thrice-daily conventional immediate-release hydrocortisone

Arm Description

Outcomes

Primary Outcome Measures

glycemic variability
glycemic variability

Secondary Outcome Measures

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

Full Information

First Posted
January 18, 2023
Last Updated
April 13, 2023
Sponsor
Vastra Gotaland Region
Collaborators
The Gothenburg Society of Medicine, Åke Wibergs Stiftelse, Sahlgrenska University Hospital, Sweden, Pilloxa
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1. Study Identification

Unique Protocol Identification Number
NCT05716607
Brief Title
Treatment Study in Patients Treated With Both Insulin & Hydrocortisone
Acronym
INSCORT
Official Title
Randomized Cross-over Trial in Patients Treated With Both Insulin & Hydrocortisone
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vastra Gotaland Region
Collaborators
The Gothenburg Society of Medicine, Åke Wibergs Stiftelse, Sahlgrenska University Hospital, Sweden, Pilloxa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Adrenal Insufficiency, Polyglandular Autoimmune Syndrome
Keywords
Insulin treatment, Hydrocortisone treatment, Opposing effects on glucose metabolism, Randomized Controlled Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Single-center, randomized, open-label, two-period cross-over trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Once-daily dual-release hydrocortisone
Arm Type
Experimental
Arm Title
Thrice-daily conventional immediate-release hydrocortisone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
OD dual-release Hydrocortisone
Other Intervention Name(s)
Once-daily dual-release hydrocortisone
Intervention Description
Treatment with once-daily dual-release hydrocortisone
Intervention Type
Drug
Intervention Name(s)
TID Hydrocortisone
Other Intervention Name(s)
Thrice-daily conventional immediate-release hydrocortisone
Intervention Description
Treatment with thrice-daily conventional immediate-release hydrocortisone
Primary Outcome Measure Information:
Title
glycemic variability
Description
glycemic variability
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
HbA1c
Description
HbA1c
Time Frame
4 weeks
Title
Time in range (glucose)
Description
Time in range (glucose)
Time Frame
4 weeks
Title
Time above range (glucose)
Description
Time above range (glucose)
Time Frame
4 weeks
Title
Time below range (glucose)
Description
Time below range (glucose)
Time Frame
4 weeks
Title
Cortisol exposure-time profile
Description
Cortisol exposure-time profile
Time Frame
4 weeks
Title
systolic blood pressure
Description
systolic blood pressure in sitting position
Time Frame
4 weeks
Title
diastolic blood pressure
Description
diastolic blood pressure in sitting position
Time Frame
4 weeks
Title
ADDIQoL
Description
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.
Time Frame
4 weeks
Title
PGWB
Description
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
Title
FIS
Description
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
Title
FOSQ
Description
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
Title
Fever
Description
Incidence of infections with high fever (patients judgement)
Time Frame
4 weeks
Title
CD16
Description
immunophenotyping of peripheral blood mononuclear cells (PBMCs) with measurement of soluble CD16
Time Frame
4 weeks
Title
ADAM17
Description
immunophenotyping of peripheral blood mononuclear cells (PBMCs) with measurement of soluble ADAM17
Time Frame
4 weeks
Title
transcriptomics
Description
RNA sequencing for large-scale study of gene expression in circulation
Time Frame
4 weeks
Title
microRNAs
Description
large-scale study of microRNAs in circulation
Time Frame
4 weeks
Title
proteomics
Description
large-scale study of proteomes (proteins produced in study subjects)
Time Frame
4 weeks
Title
metabolomics
Description
large-scale study of metabolome (metabolites produced in study subjects)
Time Frame
4 weeks
Title
hsCRP fibrinogen, immunoglobulin
Description
High-sensitivity C-reactive Protein (laboratory measurement)
Time Frame
4 weeks
Title
SR
Description
erythrocyte sedimentation rate (laboratory measurement)
Time Frame
4 weeks
Title
fibrinogen
Description
fibrinogen (laboratory measurement)
Time Frame
4 weeks
Title
immunoglobulins
Description
immunoglobulin levels in fem klasser: IgA, IgD, IgE, IgG och IgM
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dimitrios Chantzichristos, MD PhD
Phone
+46313428547
Email
dimitrios.chantzichristos@gu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dimitrios Chantzichristos, MD PhD
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Treatment Study in Patients Treated With Both Insulin & Hydrocortisone

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