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OpenTrials
Completed

NCT Number: NCT01048268

Glucose-dependent Insulinotropic Polypeptide - New Role as Blood Glucose Stabilizer?

The purpose of this study is to determine whether glucose-dependent insulinotropic polypeptide (GIP) has a stabilizing function on the blood glucose

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Department of Internal Medicine F' laboratory

Hellerup, Copenhagen County, 2900, Denmark

About this study

The aim of the study is to investigate the effect of GIP on the glucagon secretion during hyper-, eu- and hypoglycemia in healthy volunteers, patients with type 1 diabetes mellitus and patients with type 2 diabetes mellitus.

From this, we will evaluate GIP's role as blood sugar stabilizer.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Caucasians with T1DM (diagnosed according to WHO's criteria) without residual beta cell function (arginine test without increase in c-peptide) in treatment with long acting insulin OR
  • Caucasians with non-insulin treated T2DM (diagnosed according to WHO's criteria) OR
  • Caucasians without first degree relative with diabetes mellitus, with normal fasting plasma glucose and glucose tolerance along with negative islet and GAD-65 autoantibodies AND
  • Normal hemoglobin
  • Informed consent

Exclusion criteria

  • Unwillingness to participate or the wish to leave the present study
  • HbA1c > 9 %
  • Liver disease (ALAT or ASAT > 2 times normal value)
  • Diabetic nephropathy (serum creatinin > 130 microM and/or albuminury)
  • Proliferative diabetic retinopathy (anamnetic)
  • Atherosclerotic heart disease or heart failure (NYHA group III and IV)
  • Anemia
  • Treatment with medicine which cannot be paused for 12 hours
  • Pregnancy and/or breast feeding
  • Fasting plasma glucose > 15 mM on the day of the experiment

Treatment and study plan

glucose-dependent insulinotropic polypeptide

Drug

For the first 20 min of the experiment the volunteers will receive GIP at 4 pmol/kg body weight.

For the following 40 minutes the volunteers will receive 2 pmol/kg body weight

Placebo

Drug

copy GIP infusion rates

Primary outcomes

  1. The difference in glucagon secretion quantified as the difference in plasma glucagon concentration and incremental baseline-subtracted area under the curve (AUC) for plasma glucagon

    Time frame: -10, 0, 5, 10, 20, 30, 45, 60 and 90 minutes at each visit

Secondary outcomes

  1. The difference between the amount of infused glucose and the insulin responses

    Time frame: will be measured at each visit

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Registry information

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Jan 13, 2010
Registry last updated
Jul 14, 2015

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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