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Substrate Metabolism and Insulin Sensitivity in Acromegalic Patients Before and After Treatment

This study is currently recruiting participants.
Verified August 2016 by University of Aarhus
Sponsor:
ClinicalTrials.gov Identifier:
NCT00647179
First Posted: March 31, 2008
Last Update Posted: August 12, 2016
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.
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
  Purpose
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.

Condition Intervention
Acromegaly Excessive Growth Hormone Secretion Insulin Resistance Procedure: Transsphenoidal adenomectomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Substrate Metabolism and Insulin Sensitivity in Acromegalic Patients Before and After Treatment

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Insulin sensitivity [ Time Frame: Before and after treatment ]

Secondary Outcome Measures:
  • QoL, body composition, intrahepatic and intramyocellular fat, substrate metabolism, Glucose tolerance [ Time Frame: Before and after treatment ]

Biospecimen Retention:   Samples Without DNA
Whole blood, serum, muscle samples, fat samples

Estimated Enrollment: 20
Study Start Date: February 2008
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Patients recently diagnosed with acromegaly
Procedure: Transsphenoidal adenomectomy
Surgery

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patiens recently diagnoses with acromegaly, recruited from the clinic
Criteria

Inclusion Criteria:

  • Written consent
  • Age between 18 and 70
  • Recently diagnosed with acromegaly

Exclusion Criteria:

  • NYHA 3
  • Uncontrolled hypertension
  • Known cerebrovascular disease
  • Proliferative retinopatia
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00647179


Contacts
Contact: Jens Otto L. Jørgensen, Professor MD 89492025 ext +45 joj@clin.au.dk
Contact: Michael Madsen, MD 89492171 ext +45 michael.madsen@dadlnet.dk

Locations
Denmark
Department of Endocrinology, Aarhus University Hospital Recruiting
Aarhus C, Aarhus, Denmark, DK-8000
Principal Investigator: Jens Otto L. Jørgesen, Professor MD         
Sub-Investigator: Michael Madsen, MD         
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
Principal Investigator: Jens Otto L. Jørgensen, Professor MD Aarhus University Hospital, Department of Endocrinology
  More Information

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00647179     History of Changes
Other Study ID Numbers: MM-ISA-20070130
M-20070130
First Submitted: March 26, 2008
First Posted: March 31, 2008
Last Update Posted: August 12, 2016
Last Verified: August 2016

Keywords provided by University of Aarhus:
Acromegaly
Growth Hormone
Insulin resistance
Glucose tolerance
Body Composition
Substrate metabolism

Additional relevant MeSH terms:
Insulin Resistance
Acromegaly
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs