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Substrate Metabolism, Growth Hormone Signaling, and Insulin Sensitivity During Fasting

NCT ID: NCT02500095

Last Updated: 2016-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-11-30

Brief Summary

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Background: Calorie restriction increases longevity in many species and attenuate the development of chronic disorders including type 2 diabetes, cardiovascular diseases and cancer. In mice reduced activity of insulin-like growth factor I (IGF-I) and/or insulin is associated with extended longevity. Growth hormone (GH) is the main regulator of IGF-I production, but the molecular mechanism whereby GH switches from IGF-I stimulation (protein anabolism) to fatty acid oxidation (fatty acid catabolism) as well as induction of insulin resistance during fasting remains enigmatic.

Hypotheses: The changes of the global set of metabolites, induction of insulin resistance, and the shift in metabolism from protein anabolism to lipolysis together with the potentially favorable effect of calorie restriction during fasting depend on preserved fasting-induced GH secretion.

Aim: The investigators wish to provide knowledge on changes in metabolites and shift in signaling pathways that take place at the transition to the fasting state among healthy overweight and obese subjects. Furthermore the investigators wish to determine the effect of GH on the adaption of the metabolism to a fasting state.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Control

12 hours of fasting

Group Type NO_INTERVENTION

No interventions assigned to this group

Fasting and saline

72 hours of fasting and concomitant saline

Group Type EXPERIMENTAL

Fasting

Intervention Type OTHER

72 hours of fasting

Saline

Intervention Type DRUG

Concomitant saline during fasting

Fasting and GHR blockade

72 hours of fasting and concomitant Growth hormone receptor (GHR) blockade with Pegvisomant (Somavert) for inhibition of the fasting-induced GH secretion

Group Type EXPERIMENTAL

Fasting

Intervention Type OTHER

72 hours of fasting

Pegvisomant

Intervention Type DRUG

Concomitant Growth hormone receptor blockade with Pegvisomant during fasting

Interventions

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Fasting

72 hours of fasting

Intervention Type OTHER

Saline

Concomitant saline during fasting

Intervention Type DRUG

Pegvisomant

Concomitant Growth hormone receptor blockade with Pegvisomant during fasting

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* healthy men
* written consent
* body mass index (BMI) 25-40
* age 20-60 years

Exclusion Criteria

* any kind of disease
* regular medication
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jens Otto L. Jørgensen, Professor

Role: PRINCIPAL_INVESTIGATOR

Aarhus University / Aarhus University Hospital

Jens Otto L. Jørgensen, Professor

Role: STUDY_CHAIR

Aarhus University / Aarhus University Hospital

Locations

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Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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Hogild ML, Gudiksen A, Pilegaard H, Stodkilde-Jorgensen H, Pedersen SB, Moller N, Jorgensen JOL, Jessen N. Redundancy in regulation of lipid accumulation in skeletal muscle during prolonged fasting in obese men. Physiol Rep. 2019 Nov;7(21):e14285. doi: 10.14814/phy2.14285.

Reference Type DERIVED
PMID: 31724339 (View on PubMed)

Other Identifiers

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fasting8000

Identifier Type: -

Identifier Source: org_study_id