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NCT Number: NCT01173978

Insulinotropic Effect of GIP and GLP-1 Before and After Reduced Glucose Tolerance

The incretin effect in patients with type two diabetes is reduced. The investigators have previously shown that it is possible to induce a defect in the incretin effect in healthy individuals. The purpose of this study is to evaluate the insulinotropic affect of the incretin hormones in healthy individuals before and after a deterioration of the glucose homeostasis.

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Key information

Conditions

Insulin Resistance Behavior Deteriorated Glucose Homeostasis Glucose Metabolism Disorders Hyperinsulinism Inactivity Metabolic Diseases Nutritional and Metabolic Diseases Sedentary Behavior

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Clinical Physiology

Glostrup Municipality, DK-2600, Denmark

About this study

The incretin effect in patients with type two diabetes is reduced. The investigators have previously shown that it is possible to induce a defect in the incretin effect in healthy individuals. The purpose of this study is to evaluate the insulinotropic affect of the incretin hormones in healthy individuals before and after a deterioration of the glucose homeostasis. The evaluation is done by infusing GIP, GLP-1 or saline during hyperglycemic clamps.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Caucasians without type 2 diabetes mellitus
  • Normal OGTT (75 g of glucose) according to WHO's criteria
  • BMI 20-30
  • Hemoglobin > 8.0 mmol/l
  • Informed consent

Exclusion criteria

  • Liver disease (ALAT > 2 x normal level)
  • Nephropathy (s-creatinin > 130 µM or albuminuria)
  • Relatives (parents/siblings) with T2DM
  • Medical treatment witch cannot be stopped for 12 hours

Treatment and study plan

Steroid hormone

Behavioral

Steroid hormone: 37,5 mg of prednisolone; High energy diet: 130 % of recommended daily energy intake; Relative physical inactivity: no exercise and at least 8 hours of rest/day

Other names: Prednisolone

No intervention

Other

Primary outcomes

  1. Insulinotropic effect of incretin hormones

    Time frame: 12 days

    Measurements of the insulinotropic effect of incretin hormones before and after 12 days intervention with steroid treatment, high calorie diet and relative physical inactivity

Secondary outcomes

  1. Plasma concentration of glucagon

    Time frame: 12 days

    Measurements of plasma concentration of glucagon before and after 12 days intervention with steroid treatment, high calorie diet and relative physical inactivity

Sponsors and collaborators

Lead sponsor

Glostrup University Hospital, Copenhagen

Other

Collaborators

  • European Foundation for the Study of Diabetes
  • University of Copenhagen

Registry information

Official study title

Insulinotropic Effect of GIP and GLP-1 Before and After Reduced Glucose Induced by Steroid Treatment, Relative Physical Inactivity and High Calorie Diet

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Aug 3, 2010
Registry last updated
Jun 21, 2011

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.

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