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Hyperglycemia and the Extra-pancreatic Effect of Incretins

NCT ID: NCT01749163

Last Updated: 2014-12-03

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-03-31

Brief Summary

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Incretin hormones (GLP-1 and GIP) released from the intestine in response to meal ingestion augment insulin secretion from the pancreas to help maintain glycemic control. Studies in vitro and in vivo have shown that these incretin hormones also have functional effects in other tissues independent of the insulin secretory response. Both GLP-1 and GIP stimulate insulin secretion in a glucose-dependent manner, however the glucose-dependency of their extra-pancreatic effects has not been examined in vivo. By using pancreatic clamp methodology during euglycemic and hyperglycemic conditions we will test the hypothesis that extra-pancreatic effects of GLP-1 and GIP are glucose-dependent.

Detailed Description

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Conditions

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Extra-pancreatic Incretin Effect Glucose Effectiveness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Control

Saline will be coninfused during the pancreatic clamp

Group Type EXPERIMENTAL

Saline

Intervention Type BIOLOGICAL

GIP

GIP will be infused intravenously during the pancreatic clamp at 1.5 pmol/kg/min

Group Type EXPERIMENTAL

GIP

Intervention Type BIOLOGICAL

GLP-1

GLP-1 will be infused intravenously during the pancreatic clamp at 0.5 pmol/kg/min

Group Type EXPERIMENTAL

GLP-1

Intervention Type BIOLOGICAL

Interventions

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Saline

Intervention Type BIOLOGICAL

GIP

Intervention Type BIOLOGICAL

GLP-1

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* age 18-60 years
* BMI 18-30 kg/m2
* Male
* Normal glycemic control (fasting glucose \<5.6 mM)

Exclusion Criteria

* Evidence of chronic disease
* Smoking
* Active weight loss (\>2 kg in previous 6 months)
* Treatment with drugs known to affect our outcome varaibles
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Thomas Solomon

Senior Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas PJ Solomon, PhD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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Rigshospitalet

Copenhagen, Capital Region, Denmark

Site Status

Countries

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Denmark

References

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Solomon TPJ, Carter S, Haus JM, Karstoft K, von Holstein-Rathlou S, Nielsen MS, Gillum MP. Plasma FGF21 concentrations are regulated by glucose independently of insulin and GLP-1 in lean, healthy humans. PeerJ. 2022 Jan 19;10:e12755. doi: 10.7717/peerj.12755. eCollection 2022.

Reference Type DERIVED
PMID: 35111398 (View on PubMed)

Other Identifiers

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PancClamp

Identifier Type: -

Identifier Source: org_study_id