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 |
| Protocol serial number | N/A |
| Sponsor | Dutch State Mines (DSM) (The Netherlands) |
| Funder | Dutch State Mines (DSM) (The Netherlands) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, double blinded, placebo controlled crossover trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Plasma insulin, glucose |
| Primary outcome measure(s) |
Insulin and glucose response |
| Key secondary outcome measure(s) |
Hormones involved in glucose homeostasis |
| Completion date | 01/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
