A study on the effects on plasma insulin and glucose after a single meal replacement in patients with type two diabetes mellitus
| ISRCTN | ISRCTN48222371 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48222371 |
| Secondary identifying numbers | N/A |
- Submission date
- 02/05/2007
- Registration date
- 02/05/2007
- Last edited
- 10/03/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr J. Burggraaf
Scientific
Scientific
Center for Human Drug Research
Zernikedreef 10
Leiden
2333 CL
Netherlands
Study information
| Study design | Randomised, double blinded, placebo controlled crossover trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | A single oral doses of amino acids may play a role as insulin secretagogues. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Diabetes, insulin response |
| Intervention | Intervention with single meals with different composition of amino acids in a double-blind placebo controlled trial. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Plasma insulin, glucose |
| Primary outcome measure | Insulin and glucose response |
| Secondary outcome measures | Hormones involved in glucose homeostasis |
| Overall study start date | 01/04/2007 |
| Completion date | 01/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 36 |
| Key inclusion criteria | Adult Type two Diabetes Mellitus (T2DM) patients |
| Key exclusion criteria | 1. Insulin use 2. Significant clinical abnormalities |
| Date of first enrolment | 01/04/2007 |
| Date of final enrolment | 01/09/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Center for Human Drug Research
Leiden
2333 CL
Netherlands
2333 CL
Netherlands
Sponsor information
Dutch State Mines (DSM) (The Netherlands)
Industry
Industry
P.O. Box 6500
Heerlen
6401 JH
Netherlands
| Website | http://www.dsm.com/en_US/html/about/about_us_home.htm |
|---|---|
"ROR" |
https://ror.org/00k01kt20 |
Funders
Funder type
Industry
Dutch State Mines (DSM) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
