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OpenTrials
Completed

NCT Number: NCT00603031

Effect of GLP-1 and GIP on Insulin Secretion in Type-1 Diabetes Mellitus

study hypothesis: treatment with GLP-1 and/or GIP is able to potentiate the maximal stimulated insulin secretion even in c-peptide negative type-1 diabetic patients classified as having no residual beta cell function left.

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Key information

Conditions

Type-1 Diabetes Mellitus

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Endocrinology, Hvidovre Hospital

Copenhagen, 2650, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 18-60 years
  • Type-1 diabetes diagnosed between 5-40 years of age
  • Normal weight(BMI 18-27),
  • Insulin treatment from time of diagnosis.

Exclusion criteria

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

Treatment and study plan

glucagon like peptide -1

Other

continuous infusion 1,2 pmol pr. kg pr minute at 120 minutes

NaCl

Other

infusion with NaCl for 120 minutes as placebo-arm

glucose dependent insulinotropic polypeptide

Other

continuous infusion with GIP-1 (3,6pmol/kg/min) at 120 minutes.

Primary outcomes

  1. phase insulin response and phase insulin response measured as incremental area under the curve from 0-10 minutes and incremental area under the curve from 10-45 minutes respectively after iv glucose

    Time frame: 2 hours

Secondary outcomes

  1. maximal insulin response defined as mean insulin at time 47 and 49 minutes (2 and 4 minutes after infusion of L-Arginine)

    Time frame: 2 hours

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

Effect of GLP-1 and GIP on the Maximal Insulin Secretory Capacity in Type-1 Diabetes Mellitus

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jan 28, 2008
Registry last updated
Jan 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.