Objectives:To assess the effect of a single meal replacement (InsuVital®) with or without added leucine on blood levels of insulin, C-peptide and glucose in patients with T2DM.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main Parameters:
Serum concentrations and AUC of glucose, insulin, and C-peptide.
Secondary outcome
na
Background 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
(InsuVital®). 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.
Study objective
Objectives:
To assess the effect of a single meal replacement (InsuVital®) with or without
added leucine on blood levels of insulin, C-peptide and glucose in patients
with T2DM.
Study design
Study Design:
Randomized, placebo-controlled, double-blind, partial cross-over study in which
each participant will receive three of four possible treatments
Intervention
Treatments:
The treatments will consist of a drink (shake) that will be freshly prepared
prior to use. The composition of the 4 possible treatments is:
1. Carbohydrate / Fat / Vitamins & minerals
2. Carbohydrate / Fat / Vitamins & minerals / Unhydrolysed protein
3. Carbohydrate / Fat / Vitamins & minerals / InsuVital / Chromium
4. Carbohydrate / Fat / Vitamins & minerals / InsuVital / Leucine / Chromium
For each of the treatments the amount of Carbohydrate, Fat and Vitamins &
minerals will be identical. Also, the amount of InsuVital used in the
preparations for which this is applicable will be the same.
Study burden and risks
Procedures (outlay):
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.
Fleminglaan 1
2613 AX Delft
Nederland
Fleminglaan 1
2613 AX Delft
Nederland
Listed location countries
Age
Inclusion criteria
adults
>= 1 year oral anti-diabetic medication
Exclusion criteria
insulin use
significant diabetes complications
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 | NL17059.058.07 |
| Other | volgt 9 3 07 |