- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00647179
Substrate Metabolism and Insulin Sensitivity in Acromegalic Patients Before and After Treatment
December 22, 2017 updated by: University of Aarhus
The purpose of this study is to investigate the effects of chronic elevated growth hormone on metabolism and insulin sensitivity by studying acromegalic patients before and after treatment.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
27
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Aarhus
-
Aarhus C, Aarhus, Denmark, DK-8000
- Department of Endocrinology, Aarhus University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patiens recently diagnoses with acromegaly, recruited from the clinic
Description
Inclusion Criteria:
- Written consent
- Age between 18 and 70
- Recently diagnosed with acromegaly
Exclusion Criteria:
- NYHA 3
- Uncontrolled hypertension
- Known cerebrovascular disease
- Proliferative retinopatia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
Patients recently diagnosed with acromegaly
|
Surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Insulin sensitivity
Time Frame: Before and after treatment
|
Before and after treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
QoL, body composition, intrahepatic and intramyocellular fat, substrate metabolism, Glucose tolerance
Time Frame: Before and after treatment
|
Before and after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Actual)
December 7, 2016
Study Completion (Actual)
December 7, 2016
Study Registration Dates
First Submitted
March 26, 2008
First Submitted That Met QC Criteria
March 28, 2008
First Posted (Estimate)
March 31, 2008
Study Record Updates
Last Update Posted (Actual)
December 26, 2017
Last Update Submitted That Met QC Criteria
December 22, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Endocrine System Diseases
- Musculoskeletal Diseases
- Hypothalamic Diseases
- Hyperinsulinism
- Bone Diseases
- Bone Diseases, Endocrine
- Hyperpituitarism
- Pituitary Diseases
- Insulin Resistance
- Acromegaly
Other Study ID Numbers
- MM-ISA-20070130
- M-20070130
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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