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OpenTrials
Completed

NCT Number: NCT01749163

Hyperglycemia and the Extra-pancreatic Effect of Incretins

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.

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Key information

Conditions

Extra-pancreatic Incretin Effect Glucose Effectiveness

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, Capital Region, 2100, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saline

Biological

GIP

Biological

GLP-1

Biological

Primary outcomes

  1. Glucose metabolism

    Time frame: up to 4 hours

    Pancreatic clamp will be performed including infusion of somatostatin and replacement of basal insulin, glucagon, and growth hormone. During pancreatic clamps, euglycemia (5 mM) will be maintained via exogenous glucose infusion for the first 2-hours, followed by hyperglycemia (+5 mM) for the final 2-hours. An infusion of the stable isotope [U13C]glucose will be performed to assess glucose kinetics. Expired air will be collected for the analysis of [U13C]glucose into 13CO2.

  2. Lipid metabolism

    Time frame: up to 4 hours

    An infusion of the stable isotope [D5]glycerol will be performed to assess glycerol kinetics.

Secondary outcomes

  1. Endothelial function

    Time frame: Baseline, 2 hours, and 4 hours

    Ultrasound Doppler will be used to examine lower and upper limb blood flow and flow-mediated dilation

  2. Signaling

    Time frame: Baseline, 2 hours, and 4 hours

    Skeletal muscle (vastus lateralis) and subcutaneous abdominal adipose biopsies will be obtained under local anaesthetic by the Bergstrom needle technique. Intracellular signalling related to glucose and lipid metabolism will be measured.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

Determining the Extra-pancreatic Effects of Incretin Hormones During Euglycemic and Hyperglycemic Pancreatic Clamps

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Dec 13, 2012
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.