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NCT Number: NCT03210545

A Study of Markers of Glucocorticoid Effects in Patients With Addisons Disease (DOSCORT)

DOSCORT is a 2-dose, cross-over study primarily aiming to identify and validate novel biological markers (biomarkers) of glucocorticoid effect in the human body. Patients with Addison´s disease, primary adrenal insufficiency, with life-long glucocorticoid replacement therapy will undergo 2 treatment periods where their usual hydrocortisone treatment will be replaced with betamethasone in physiological and supra physiological doses. Blood, saliva, urine, health related Quality-of-life self-assessment forms, measurements of physical activity and sleep quality will be collected from both treatment periods.

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Key information

Conditions

Addison Disease Adrenal Gland Diseases Adrenal Insufficiency Autoimmune Diseases Endocrine System Diseases Immune System Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centrum for Endocrinology and Metabolism, Sahlgenska University Hospital

Gothenburg, 413 45, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females at ages 20-65 years
  • Previously diagnosed (e.g. more than 12 months ago) with primary adrenal insufficiency due to autoimmune adrenalitis, i.e. Addison´s disease
  • A stable daily glucocorticoid replacement dose for at least 3 months prior to study entry
  • An oral glucocorticoid replacement dose of 15-30 mg Hydrocortisone total daily dose
  • If needed, a stable fludrocortisone replacement dose for at least 3 months prior to study entry
  • Body mass index (BMI) of 20-35 kg/m2
  • Ability to comply to the protocol procedures and having signed informed consent to participate in the study

Exclusion criteria

  • Clinical or laboratory signs of significant cerebral, cardiovascular, respiratory, hepaticobiliary/ pancreatic disease which in the investigators judgement may interfere with the study assessment of completion of the study
  • Clinically significant renal dysfunction with a serum creatinine above 150 mmol/L
  • Pregnant or lactating women
  • Diabetes Mellitus
  • Systemic infections
  • Regular dehydroepiandrosterone (DHEA) medication for the past 4 weeks
  • Any medication with agents which in the investigators judgement might interfere with the study drugs kinetics, including therapies affecting gastro intestinal emptying or motility
  • Alcohol/drug abuse or any other condition associated with poor patient compliance, including expected non-cooperation, as judged by the investigator
  • Hypersensitivity to the active substance or any excipients used in the study drug of choice
  • Any additional underlying disease that may need regular or periodic pharmacological treatment with glucocorticoids during the trail, such as asthma, skin- or eye conditions treated with inhaled or topical glucocorticoids
  • Any additional underlying condition that needs treatment with intramuscular or intra-articular steroid injections during the trial

Treatment and study plan

Betamethasone

Drug

A cross-over study where patients with Addison´s disease will undergo two treatment periods where their usual hydrocortisone replacement therapy will be replaced by the glucocorticoid betamethasone in physiological and supra physiological doses. A wash-out period of 2-5 weeks in-between the treatment periods will be carried out where participants intake their usual hydrocortisone replacement therapy.

Primary outcomes

  1. Protein profile changes between physiological and supra physiological doses of betamethasone.

    Time frame: Changes in proteome (g/dl or umol/l) during 7 days of treatment with two different doses of betamethasone

    By using mas spectrometry, protein profile changes in blood, urine and saliva will be identified at four timepoints: after 3 hours and after 7 days during treatment with betamethasone in a physiological dose and after 3 hours and after 7 days during treatment with betamethasone in a supra physiological dose.

  2. Metabolite profile changes between physiological and supra physiological doses of betamethasone.

    Time frame: Changes in metabolome (units depending on the kind of metabolome) during 7 days of treatment with two different doses of betamethasone

    By using mas spectrometry, metabolite profile changes in blood, urine and saliva will be identified at four timepoints: after 3 hours and after 7 days during treatment with betamethasone in a physiological dose and after 3 hours and after 7 days during treatment with betamethasone in a supra physiological dose.

Secondary outcomes

  1. Messenger RNA (mRNA)/miRNA profile changes between physiological and supra physiological doses of betamethasone.

    Time frame: Changes in mRNA/miRNA (Svedberg Unit, S) during 7 days of treatment with two different doses of betamethasone

    By using array based transcriptomics (both mRNA and miRNA), mRNA/miRNA profile changes in blood, urine and saliva will be identified at four timepoints: after 3 hours and after 7 days during treatment with betamethasone in a physiological dose and after 3 hours and after 7 days during treatment with betamethasone in a supra physiological dose.

  2. Changes in glucose metabolism between physiological and supra physiological doses of betamethasone.

    Time frame: Changes in glucose metabolism (units depending on sample analysis) during 7 days of treatment with two different doses of betamethasone

    Conventional markers for glucose metabolism in blood will be identified at four timepoints: after 3 hours and after 7 days during treatment with betamethasone in a physiological dose and after 3 hours and after 7 days during treatment with betamethasone in a supra physiological dose.

  3. Changes in lipid-profile between physiological and supra physiological doses of betamethasone.

    Time frame: Changes in lipid-profile (units depending on sample analysis) during 7 days of treatment with two different doses of betamethasone

    Conventional markers for lipid-profile in blood will be identified at four timepoints: after 3 hours and after 7 days during treatment with betamethasone in a physiological dose and after 3 hours and after 7 days during treatment with betamethasone in a supra physiological dose.

  4. Changes in bone-markers between physiological and supra physiological doses of betamethasone.

    Time frame: Changes in levels of bone-markers in blood (units depending on sample analysis) during 7 days of treatment with two different doses of betamethasone

    Bone-markers in blood will be identified at four timepoints: after 3 hours and after 7 days during treatment with betamethasone in a physiological dose and after 3 hours and after 7 days during treatment with betamethasone in a supra physiological dose.

  5. Changes in self-reported Quality of Life between physiological and supra physiological doses of betamethasone using the Addison-specific Quality of Life questionnaire (ADDIQoL).

    Time frame: Changes in units of the ADDIQoL questionnaire (units on a scale) after 7 days of treatment with two different doses of betamethasone

    Self-reported health-related quality of life and general well-being will be assessed using the ADDIQoL questionnaire after 7 days of treatment with a physiological dose of betamethasone and after 7 days of treatment with a supra physiological dose of betamethasone.

  6. Changes in self-reported Quality of Life between physiological and supra physiological doses of betamethasone using the Psychological General Well-being (PGWB) index.

    Time frame: Changes in units of the PGWB index (units on a scale) after 7 days of treatment with two different doses of dexamethasone

    Self-reported health-related quality of life and general well-being will be assessed using the PGWB index after 7 days of treatment with a physiological dose of betamethasone and after 7 days of treatment with a supra physiological dose of betamethasone.

  7. Changes in self-reported quality of life and fatigue between physiological and supra physiological doses of betamethasone using the Fatigue impact scale (FIS)

    Time frame: Changes in units in the FIS (units on a scale) after 7 days of treatment with two different doses of betamethasone

    Self-reported health-related quality of Life, general well-being and fatigue will be assessed using the FIS questionnaire after 7 days of treatment with a physiological dose of betamethasone and after 7 days of treatment with a supra physiological dose of betamethasone.

  8. Changes in self-reported quality of life and fatigue between physiological and supra physiological doses of betamethasone using the Functional Outcomes of Sleep Questionnaire (FOSQ).

    Time frame: Changes in units in the FOSQ (units on a scale) after 7 days of treatment with two different doses of betamethasone

    Self-reported health-related quality of life, general well-being and fatigue will be assessed using FOSQ after 7 days of treatment with a physiological dose of betamethasone and after 7 days of treatment with a supra physiological dose of betamethasone.

  9. Changes in daily physical activity between physiological and supra physiological doses of betamethasone

    Time frame: Changes in daily physical activity (units provided in connected software) after 7 days of treatment with two different doses of betamethasone

    Daily physical activity will be objectively evaluated using a wrist accelerometer during 7 days of treatment with a physiological dose of betamethasone and during 7 days of treatment with a supra physiological dose of betamethasone.

  10. Changes in sleep quality between physiological and supra physiological doses of betamethasone

    Time frame: Changes in sleep quality (measurements and units provided in connected software) after 7 days of treatment with two different doses of betamethasone

    Sleep quality will be objectively evaluated using a wrist worn sleep monitor during the last night of a 7 day treatment period with a physiological dose of betamethasone and the last night of a 7 day treatment period with a supra physiological dose of betamethasone.

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Registry information

Official study title

A Dose-response Study of Markers of Glucocorticoid Effects (DOSCORT): A Double-blinded, Randomized, 2-dose, Cross-over Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jul 7, 2017
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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