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OpenTrials
Completed

NCT Number: NCT01414556

GIP Effects at Insulin Induced Hypoglycemia in Patients With Type 2 Diabetes

Investigation of GIP effects at fasting and hypoglycemia

Completed

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Gentofte Hospital

Hellerup, 2900, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Caucasians 18 years or older with Type 2 diabetes (WHO criteria)

Exclusion criteria

  • HbA1c >9 %
  • Liver disease (ALAT/ASAT >2 x upper normal limit)
  • Diabetic nephropathy (s-creatinine >130 µM or albuminuria)
  • Proliferative diabetic retinopathy (anamnestic)
  • Severe arteriosclerosis or heart failure (NYHA group III og IV)
  • Anemia
  • treatment with medication not applicable to pause for 12 hours
  • Fasting plasma glucose >15 mM on screening day.

Treatment and study plan

Glucose-dependent Insulinotropic polypeptide

Other

infusion 4 pmol x kg x min first 15 min, thereafter 2 pmol x kg x min

Saline

Other

Primary outcomes

  1. glucagon/insulin(c-peptide) absolute, incremental and area under curve values

    Time frame: approx. 15 minutes intervals, time 0 to 120 min

Secondary outcomes

  1. plasma gut hormones and nutrients

    Time frame: approx. 15 minutes intervals, time 0 to 120 min

Sponsors and collaborators

Lead sponsor

Mikkel Christensen

Other

Registry information

Official study title

Effects of Glucose-dependent Insulinotropic Polypeptide at Insulin Induced Hypoglycemia in Patients With Type 2 Diabetes

Acronym: GIP-HYPO-T2DM

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 11, 2011
Registry last updated
Apr 2, 2013

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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