|- candidate number||3084|
|- NTR Number||NTR1237|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||22-feb-2008|
|- Secondary IDs||P07200-1 MEC LUMC|
|- Public Title||Effects of 5 or 10 gram of a protein hydrolysate on serum insulin and glucose levels in patients with type 2 diabetes mellitus |
|- Scientific Title||Effects of 5 or 10 gram of a protein hydrolysate on serum insulin and glucose levels in patients with type 2 diabetes mellitus |
|- hypothesis||5 and 10 grams of a protein hydrolysate effectively increase insulin secretion and lowers plasma glucose levels after a carbohydrate load in type 2 diabetes mellitus (DM-2)|
|- Healt Condition(s) or Problem(s) studied||Diabetes Mellitus Type 2 (DM type II), Protein hydrolysate , Glucose levels |
|- Inclusion criteria||1. Males or females, 18-70 years old. |
2. Fasting glucose level > 7 mmol/L after 2 days refraining from medication.
3. Are on stable medication with biguanides for at least 3 months.
4. Prepared and able to give written informed consent;
|- Exclusion criteria||1. Use of insulin, sulfonylurea derivatives, meglitinides or other antidiabetic drugs except biguanides. |
2. BMI > 35 kg/m2.
3. Females who are pregnant, have the intention to become pregnant within the study period, or who are lactating.
4. A present and clinically significant history of ischemic heart disease (such as angina pectoris with an incidence of more than one attack/month), acute myocardial infarction within one year prior to the study or congestive heart failure (defined as NYHA class III or IV).
5. Uncontrolled hypertension.
6. Active, proliferative retinopathy.
7. Active or history of liver disease or impaired renal function (defined as a creatinin clearance calculated with the Cockcroft-Gault formula below 60 ml/min).
8. Participation in a trial within 3 months prior to the start of the study or more then 4 times a year.
9. Loss of 250 ml or more of blood within 3 months prior to screening.
10. Any clinical condition, including use of co-medication or laboratory test results that in the opinion of the investigators may jeopardize the health status of the participants.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2008|
|- planned closingdate||1-aug-2008|
|- Target number of participants||12|
|- Interventions||The treatments will consist of a drink that will be freshly prepared prior to use. The drink will be administered as a single oral bolus (300 mL) containing 50 g of carbohydrate (50% glucose and 50% maltodextrin) with 0, 5, or 10 g protein hydrolysate|
|- Primary outcome||Serum concentrations and AUC of glucose and insulin|
|- Secondary outcome||N/A|
|- Timepoints||Baseline, 15, 30, 45, 60. 90 and 120 minutes|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. J.W.A. Smit|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. J.W.A. Smit|
|- Sponsor/Initiator ||DSM Food Specialties|
(Source(s) of Monetary or Material Support)
|DSM Food Specialties|
|- Brief summary||Rationale: |
There is accumulating evidence that amino acids such as leucine play a role as insulin
secretagogues. One possible clinical application that is currently explored is a protein hydrolysate. Research with this product has shown that co-ingestion of this product with carbohydrate augments the insulin response and enhances glucose disposal.
Previous experiments were carried out with a relatively high dose of protein. Hence, information on interventions with a lower protein load is necessary. Part I of the current study will address the efficacy of 5 and 10 g of the hydrolysate in lowering blood levels of insulin and glucose in patients with type 2 diabetes mellitus (T2DM).
The objective of this study is to demonstrate the efficacy of a single 5-g and 10-g dose of the hydrolysate on blood levels of insulin and glucose in patients with T2DM.
Randomized, placebo-controlled, double-blind, cross-over study with 3 study-days, separated by 7-day intervals.
The study will be carried out in 12 patients, 18 - 70 years of age, with an established diagnosis of T2DM treated by oral anti-diabetic therapy for at least 3 years.
The treatments will consist of a drink that will be freshly prepared prior to use. The drink will be administered as a single oral bolus (300 mL) containing 50 g of carbohydrate (50% glucose and 50% maltodextrin) with 0, 5, or 10 g of the hydrolysate.
Drinks will be flavored by adding 0.2 g sodium saccharinate, 1.8 g citric acid, and 5 g cream vanilla flavor (Quest International) per liter of beverage.
Serum concentrations and AUC of glucose and insulin.
|- Main changes (audit trail)|
|- RECORD||22-feb-2008 - 25-mrt-2008|