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Completed

NCT Number: NCT00612950

Beta-Cell Function After Near-Normalisation of Blood Glucose

The incretin effect is attenuated in patients with type 2 diabetes mellitus partly due to impaired potentiation of beta-cell responsiveness to glucose by glucose dependent insulinotropic polypeptide and glucagon-like peptide-1 respectively. The aim of the present study was to investigate whether 4 weeks of near-normalization of blood glucose could improve the insulin responses to GIP and GLP-1 in patients with type 2 diabetes.

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Key information

Conditions

Type 2 Diabetes 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

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Endocrinology, Hvidovre Hospital

Copenhagen, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 18-70 years
  • Type 2 diabetes diagnosed after 30 years of age
  • BMI > 25

Exclusion criteria

  • Severe complications to diabetes
  • Abnormal liver and kidney function
  • Haemoglobin below the lower limit
  • Macroalbuminuria
  • Systemic disease
  • Pregnancy

Treatment and study plan

glucagon-like peptide-1,

Drug

GLP-1:continuous infusion of ½ pmol/kg/min for a total time of 120 minutes.

glucose dependent insulinotropic polypeptide

Drug

continuous infusion of GIP (1½ pmol/kg/min) for 120 min.

Saline

Drug

continuous infusion of Saline for 120 min

Primary outcomes

  1. 2.phase insulin response measured as incremental area under the curve from 10-120 minutes

    Time frame: 2 hours

Secondary outcomes

  1. 2.phase insulin response measured as incremental area under the curve from 10-120 minutes, after 4 weeks of insulin treatment

    Time frame: 2 hours

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

Four Weeks of Near Normalisation of Blood Glucose Improves the Insulin Response to GLP-1 and GIP in Patients With Type 2 Diabetes

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Feb 12, 2008
Registry last updated
Feb 12, 2008

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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