Part I: The objective of Part I of this study is the efficacy of a single 5-g and 10-g dose of InsuVital* on blood levels of insulin and glucose in patients with T2DM.Part II: The objective of Part II of this study is to assess the effect of a 10-g…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Serum concentrations and AUC of glucose and insulin.
Secondary outcome
na
Background summary
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 (InsuVital*). 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
InsuVital in lowering blood levels of insulin and glucose in patients with type
2 diabetes mellitus (T2DM).
Previous experiments were also carried out with a high dose of carbohydrate. It
is not known if InsuVital* is efficacious in the presence of lower carbohydrate
doses.
Part II of the current study will therefore address the efficacy of a fixed
dose of InsuVital, combined with either a low or a high carbohydrate load in
lowering blood levels of insulin and glucose in patients with T2DM.
Study objective
Part I: The objective of Part I of this study is the efficacy of a single 5-g
and 10-g dose of InsuVital* on blood levels of insulin and glucose in patients
with T2DM.
Part II: The objective of Part II of this study is to assess the effect of a
10-g dose of InsuVital* on blood levels of insulin and glucose in patients with
T2DM, combined with a 25 or 50g carbohydrate load.
Study design
Randomized, placebo-controlled, double-blind, cross-over study with 3
study-days, separated by 7-day intervals.
Intervention
Part I: 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 InsuVital*.
Part II: Patients will receive a freshly prepared drink containing 25 or 50 g
of carbohydrate (50% glucose and 50% maltodextrin) with 10 g InsuVital*or 50 g
without InsuVital* as a negative control.
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.
Study burden and risks
na
PO Box 1
2600 MA Delft
Nederland
PO Box 1
2600 MA Delft
Nederland
Listed location countries
Age
Inclusion criteria
• Males or females, 18-70 years old.
• Fasting glucose level > 7 mmol/L after 2 days refraining from medication.
• Are on stable medication with biguanides for at least 3 months.
• Prepared and able to give written informed consent;
Exclusion criteria
• Use of insulin, sulfonylurea derivatives, meglitinides or other antidiabetic drugs except biguanides;
• BMI > 35 kg/m2;
• Females who are pregnant, have the intention to become pregnant within the study period, or who are lactating;
• 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);
• Uncontrolled hypertension;
• Active, proliferative retinopathy
• 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);
• Participation in a trial within 3 months prior to the start of the study or more then 4 times a year;
• Loss of 250 ml or more of blood within 3 months prior to screening;
• 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL19875.058.07 |