Importance of the GH/IGF-1 Axis for Human Substrate and Energy Metabolism During Calorie Restriction

September 12, 2011 updated by: Birgitte Nellemann, University of Aarhus
This study will investigate whether growth hormone is modulated by the enzyme SIRT1 and by that is stimulating lipolysis on expense of IGF-I production. This is done in 10 healthy men on calorie restriction on 4 study days with fat and skeletal muscle biopsies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

It has been shown that calorie restriction enhances the length of life in yeast, worms, fish and rodent. Whether this elongation of life due to calorie restriction can be applied to humans is not known. However, it is a fact that calorie restriction will decrease the risk of developing metabolic disturbances such as diabetes, hypertension and atherosclerosis.

On the molecular level the specific relations are not fully understood. This study will investigate the possible connection between SITR1 and the relation to the GH/IGF-I axis and STAT5b in healthy men. The participant will fast 42 and 12 hours respectively, and have GH or placebo infusions. The design is a classical 2x2 design and will be randomized.

Knowledge of the interactions between calorie restriction, SIRT1, STAT5b and the GH/IGF-I axis will apply important information about the relations between aging, energy metabolism and metabolic disturbances.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

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

  • Denmark
      • Aarhus, Denmark, 8000
        • University Hospital of Aarhus, Norrebrogade

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

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • healthy lean men
  • age >18

Exclusion Criteria:

  • metabolic disturbances
  • alcohol drug abuse
  • malign disease: current or previous

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

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 42 hour fast/GH infusion
Drug: GH hormone infusion
Norditropin 30 ng/kg/min
Other Names:
  • Genotropin
  • Norditropin
Behavioral: 42 hour fast
The participant will be fasting 42 hours prior to the start of the study day, drinking water is allowed
Other Names:
  • No other name
Experimental: 42 hour fast/Placebo infusion
Behavioral: 42 hour fast
The participant will be fasting 42 hours prior to the start of the study day, drinking water is allowed
Other Names:
  • No other name
Experimental: 12 hour fast/GH infusion
Drug: GH hormone infusion
Norditropin 30 ng/kg/min
Other Names:
  • Genotropin
  • Norditropin
Behavioral: 12 hour fast
12 hour fast will be used as a control scenario to 42 hour fast
Other Names:
  • No other name
Placebo Comparator: 12 hour fast/Placebo infusion
Behavioral: 12 hour fast
12 hour fast will be used as a control scenario to 42 hour fast
Other Names:
  • No other name

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of intracellular pathways to clarify the interplay between calorie restriction, SIRT1, STATb5, and the GH/IGF-I axis
Time Frame: 6 hour study days
All study days consists of 3 hour basic periods and 3 hours hyperinsulinemic, euglycemic clamp.
6 hour study days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Jens Otto L Jørgensen, Professor, University Hospital of Aarhus

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.

General Publications

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

September 1, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

September 24, 2010

First Submitted That Met QC Criteria

September 24, 2010

First Posted (Estimate)

September 27, 2010

Study Record Updates

Last Update Posted (Estimate)

September 13, 2011

Last Update Submitted That Met QC Criteria

September 12, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-20100150

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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