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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01209429

Enrollment

Registered

2010-09-27

Start date

2010-09-30

Completion date

2011-09-30

Last updated

2011-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Calorie restriction, GH/IGF-I axis, STATb5, SIRT1, Intracellular signaling peptides and proteins, Fasting, Growth hormone, IGF-1

Brief summary

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.

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.

Interventions

DRUGGH hormone infusion

Norditropin 30 ng/kg/min

BEHAVIORAL42 hour fast

The participant will be fasting 42 hours prior to the start of the study day, drinking water is allowed

BEHAVIORAL12 hour fast

12 hour fast will be used as a control scenario to 42 hour fast

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

* healthy lean men * age \>18

Exclusion criteria

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

Design outcomes

Primary

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026