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Completed

NCT Number: NCT00612625

Near Normalisation of BG Improves the Potentiating Effect of GLP-1

The ability of glucagon-like peptide 1 to enhance beta-cell responsiveness to I.v. glucose is impaired in patients with type 2 diabetes mellitus compared with healthy individuals. We investigated whether 4 weeks of near-normalisation og blood glucose improves the potentiation of glucose-stimulated insulin secretion by GLP-1

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Key information

Conditions

Diabetes Mellitus Type 2 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 og kidney function
  • Haemoglobin below the lower limit
  • Macroalbuminuria
  • Systemic disease
  • Pregnancy

Treatment and study plan

glucagon-like peptide-1

Drug

continuous infusion of GLP-1 (1½ pmol/kg/min)

Saline

Drug

continuous infusion of saline

Primary outcomes

  1. insulin secretion rate (ISR) were derived by deconvolution of c-peptide. ISR is expressed as pmol/kg/min

    Time frame: 180 minutes

Secondary outcomes

  1. The calculated ISR values was plotted against the ambient plasma glucose. The slopes of this linear relationships were calculated by cross-correlation analysis and is and estimation of beta-cell responsiveness (pmol/kg/min)/mmol/l

    Time frame: 180 minutes

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

Near Normalisation of Blood Glucose Improves the Potentiating Effect of GLP-1 on Glucose Induced Insulin Secretion in Patients With Type 2 Diabetes

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
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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