| - candidate number | 2531 |
| - NTR Number | NTR942 |
| - ISRCTN | ISRCTN48222371 |
| - Date ISRCTN created | 2-mei-2007 |
| - date ISRCTN requested | 20-apr-2007 |
| - Date Registered NTR | 27-mrt-2007 |
| - Secondary IDs | N/A |
| - Public Title | A study on the effects on plasma insulin and glucose after a single meal replacement in patients with T2DM. |
| - Scientific Title | A study on the effects on plasma insulin and glucose after a single meal replacement in patients with T2DM. |
| - ACRONYM | N/A |
| - hypothesis | A single oral doses of amino acids may play a role as insulin secretagogues. |
| - Healt Condition(s) or Problem(s) studied | Diabetes Mellitus, Insulin response |
| - Inclusion criteria | Adult T2DM patients. |
| - Exclusion criteria | 1. Insulin use; 2. Significant clinical abnormalities. |
| - mec approval received | no |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Placebo |
| - group | Crossover |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-apr-2007 |
| - planned closingdate | 1-sep-2007 |
| - Target number of participants | 36 |
| - Interventions | Intervention with single meals with different composition of amino acids in a double-blind placebo controlled trial. |
| - Primary outcome | Insulin and glucose response. |
| - Secondary outcome | Hormones involved in glucose homeostasis. |
| - Timepoints | N/A |
| - Trial web site | http://www.chdr.nl |
| - status | inclusion stopped: follow-up |
| - CONTACT FOR PUBLIC QUERIES | MD. J. Burggraaf |
| - CONTACT for SCIENTIFIC QUERIES | MD. J. Burggraaf |
| - Sponsor/Initiator | DSM |
| - Funding (Source(s) of Monetary or Material Support) | DSM |
| - Publications | N/A |
| - Brief summary | Rationale: There is accumulating evidence that amino acids such as leucine play a role as insulin secretagogues. One of possible clinical application that is currently explored is a mixture of protein hydrolysate and an amino acid mixture. Research with this product has shown that co-ingestion of this product with carbohydrate augments the insulin response and enhances glucose disposal. These effects are observed in patients with both a recent and long-standing diagnosis of T2DM. However, previous experiments were carried out with a relatively high dose of protein that may be potentially detrimental for the renal function in T2DM patients, especially when the product is used chronically. Hence, information on interventions with a lower protein load is necessary. Therefore a study will be performed with the product in a relatively low dose with or without added leucine on blood levels of insulin and glucose in diabetic subjects. The treatments will consist of drinks that will be freshly prepared prior to use. There are four possible treatments with a different composition of protein. Potential participants will be recruited using the CHDR database, contacts with dept of Endocrinology of LUMC and general practioners and advertisements. After an information session and upon providing informed consents patients will be medically screened. When no objections against participation in the study can be identified during the screening the patients will be invited to visit CHDR 3 times, with each visit separated by at least 7 days. At each visit they will be given one of the study treatments and blood sampling for glucose metabolism will take place for a period of 4 hours. |
| - Main changes (audit trail) | |
| - RECORD | 27-mrt-2007 - 9-dec-2009 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl