Condition category
Nutritional, Metabolic, Endocrine
Date applied
02/05/2007
Date assigned
02/05/2007
Last edited
10/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.chdr.nl

Contact information

Type

Scientific

Primary contact

Dr J. Burggraaf

ORCID ID

Contact details

Center for Human Drug Research
Zernikedreef 10
Leiden
2333 CL
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

A single oral doses of amino acids may play a role as insulin secretagogues.

Ethics approval

Not provided at time of registration

Study design

Randomised, double blinded, placebo controlled crossover trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Diabetes, insulin response

Intervention

Intervention with single meals with different composition of amino acids in a double-blind placebo controlled trial.

Intervention type

Drug

Phase

Not Specified

Drug names

Plasma insulin, glucose

Primary outcome measures

Insulin and glucose response

Secondary outcome measures

Hormones involved in glucose homeostasis

Overall trial start date

01/04/2007

Overall trial end date

01/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Adult Type two Diabetes Mellitus (T2DM) patients

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

36

Participant exclusion criteria

1. Insulin use
2. Significant clinical abnormalities

Recruitment start date

01/04/2007

Recruitment end date

01/09/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Center for Human Drug Research
Leiden
2333 CL
Netherlands

Sponsor information

Organisation

Dutch State Mines (DSM) (The Netherlands)

Sponsor details

P.O. Box 6500
Heerlen
6401 JH
Netherlands

Sponsor type

Industry

Website

http://www.dsm.com/en_US/html/about/about_us_home.htm

Funders

Funder type

Industry

Funder name

Dutch State Mines (DSM) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes