Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Acromegaly - Before and After Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03431727
Recruitment Status : Recruiting
First Posted : February 13, 2018
Last Update Posted : December 7, 2020
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Tracking Information
First Submitted Date December 22, 2017
First Posted Date February 13, 2018
Last Update Posted Date December 7, 2020
Actual Study Start Date October 1, 2017
Estimated Primary Completion Date December 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 12, 2018)
  • Sleep apnea [ Time Frame: At baseline (time of diagnosis) and at an average of 1 years treatment ]
    ApneaLinkAir: respiratory effort, puls, oxygen saturation, nasal flow and snoring
  • Circulation [ Time Frame: At baseline (time of diagnosis) and at an average of 1 years treatment ]
    Sphygmocor: central arterial pressure and pulse wave velocity
  • Bone metabolism [ Time Frame: At baseline (time of diagnosis) and at an average of 1 years treatment ]
    HRpQCT scan
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 12, 2018)
  • Heartfunction [ Time Frame: At baseline (time of diagnosis) and at an average of 1 years treatment ]
    Echocardiography
  • Substrate metabolism; signaling proteins [ Time Frame: At baseline (time of diagnosis) and at an average of 1 years treatment ]
    Western blotting
  • Substrate metabolism; gene targets [ Time Frame: At baseline (time of diagnosis) and at an average of 1 years treatment ]
    qPCR
  • Energy expenditure [ Time Frame: At baseline (time of diagnosis) and at an average of 1 years treatment ]
    Indirect calorimetry
  • Body composition [ Time Frame: At baseline (time of diagnosis) and at an average of 1 years treatment ]
    DXA scan
  • Physical activity [ Time Frame: At baseline (time of diagnosis) and at an average of 1 years treatment ]
    Sensoriband
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Acromegaly - Before and After Treatment
Official Title Sleep Apnea, Circulation and Metabolism in Acromegaly - Before and After Treatment
Brief Summary The aim of the study is to investigate sleep apnea, circulation and metabolism in acromegaly before and after surgery and/or medical treatment.
Detailed Description Acromegaly is a rare disease caused by a growth hormone (GH) producing pituitary adenoma. Surgery is primary treatment, whereas medical treatment with a somatostatin analogue (SA), which suppresses GH secretion and reduces tumour size, is used when surgery is insufficient or unfeasible. Acromegaly is associated with metabolic abnormalities which contributes to an increased morbidity and mortality if left untreated. To which extend these abnormalities reverses after treatment, and if treatment modality influences the outcome, remain elusive. The aim of the study is to investigate sleep apnea, circulation and metabolism in acromegaly before and after surgery and/or medical treatment
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood samples and tissue will be kept in a locked freezer thorughout the study period
Sampling Method Non-Probability Sample
Study Population Newly diagnosed acromegalic patients
Condition
  • Acromegaly
  • Growth Hormone Treatment
  • Sleep Apnea
  • Cardiovascular Diseases
  • Bone Diseases
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 12, 2018)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 1, 2022
Estimated Primary Completion Date December 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Recently diagnosed with acromegaly
  • Age above 18
  • Written consent

Exclusion Criteria:

- Pregnancy

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Mai C Arlien-Søborg, MD +45 23837420 mas@clin.au.dk
Contact: Jens Otto L Jørgensen, Professor +45 24800664 joj@clin.au.dk
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT03431727
Other Study ID Numbers 1-10-72-126-16
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Aarhus
Study Sponsor University of Aarhus
Collaborators Not Provided
Investigators
Principal Investigator: Jens Otto L Jørgensen, Porfessor Aarhus University Hospital, Department of internal medicine and endocrinology
PRS Account University of Aarhus
Verification Date December 2020