NCT00876213

Brief Summary

The aim of this proposal is to dissect the mechanisms controlling gastric emptying, appetite and food intake in humans, and to obtain new knowledge to fight obesity on a pharmacological basis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 6, 2009

Completed
Last Updated

April 6, 2009

Status Verified

April 1, 2009

First QC Date

April 3, 2009

Last Update Submit

April 3, 2009

Conditions

Diabetes

Keywords

AmylinGLP-1gastric emptyingappetite and food intake

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with type 1 diabetes and matched healthy control subjects

You may qualify if:

  • Patients with type 1 diabetes
  • Informed oral and written consent
  • Caucasians over the age of 18 years with type 1 diabetes (diagnosed according to the criteria of WHO) receiving long acting insulin
  • C-peptide negative glucagon test
  • Normal blood haemoglobin concentration
  • Healthy control subjects
  • Informed oral and written consent
  • Caucasians over the age of 18 years
  • Normal 75 g- oral glucose tolerance test (OGTT) according to the criteria of WHO
  • Negative islet cell autoantibodies (ICA) and GAD-65 autoantibodies
  • No first-degree relatives with diabetes
  • Normal blood haemoglobin concentration

You may not qualify if:

  • Patients with type 1 diabetes
  • Residual beta-cell function (evaluated with glucagon test)
  • Impaired hepatic function (aspartate aminotransferase (ASAT) and/or alanine aminotransferase (ALAT) \> 2 times upper normal limit)
  • Diabetic nephropathy (serum-creatinine \> 130 µM and/or albuminuria)
  • Diabetic neuropathy
  • Proliferative diabetic retinopathy
  • Pregnancy, breastfeeding or intention of becoming pregnant or judged to be using inadequate contraceptive measures
  • Healthy control subjects
  • Impaired hepatic function (ASAT or ALAT \> 2 times upper normal limit)
  • Impaired renal function (serum-creatinine \> 130 μM and/or albuminuria)
  • First-degree relatives with diabetes
  • Pregnancy, breastfeeding or intention of becoming pregnant or judged to be using inadequate contraceptive measures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre Hospital

Hvidovre, Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Meena Asmar, MD,Ph.Dstud.

    Panum Institut

    PRINCIPAL INVESTIGATOR

  • Jens Juul Holst, Professor,MD

    Panum Institut

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 3, 2009

First Posted

April 6, 2009

Study Start

March 1, 2007

Study Completion

June 1, 2008

Last Updated

April 6, 2009

Record last verified: 2009-04

Locations

DK(1)