To study the influence of ingestion of additional leucine on body composition and muscle characteristics in elderly, type 2 diabetes patients.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Muscle disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Body composition and muscle characteritics will be compared on 0, 3 and 6
months of the intervention.
Secondary outcome
Maximal strength
Lipid profile
Cognitive function
HbA1c
Plasma glucose responses
Background summary
Aging and type 2 diabetes are associated with a decrease in muscle synthesis,
which is one of the main causes for decreased muscle mass and muscle function.
This process leads to a decreased performance, decreased ability to live
independently, increased risk to become obese, osteoporosis and cardiovascular
diseases.
To increase muscle protein synthesis it is essential that building blocks from
nutrition are available in the body. Recent research has shown that amino acid
supplements can lead to an increase in muscle protein synthesis. The increased
muscle protein synthesis after amino acid intake can lead to an increase of
muscle mass and an improved performance of the muscles. At the moment there are
indications that certain amino acids after intake have a stimulating effect on
insulin secretion. This could have a positive effect for type 2 diabetes,
because the intake of certain amino acids could improve plasma glucose respons.
In the present study we will investigate to what extent the intake of leucine
(an essential amino acid) supplements can influence body composition, muscle
characteristics and plasma glucose respons in elderly, type 2 diabetes
patients.
Study objective
To study the influence of ingestion of additional leucine on body composition
and muscle characteristics in elderly, type 2 diabetes patients.
Study design
2 groups of elderly, type 2 diabetes patients will perform a 6 month placebo
controlled trial with 2.5 g additional leucine or placebo supplementation per
meal.
Body composition and muscle characteristics will be compared at 0, 3 and 6
months time of the intervention.
Intervention
A 6 month placebo controlled trial. During these 6 months 30 subjects will take
leucine supplementation en 30 subjects will take placebo supplements. Daily the
subjects will take 7.5 g leucine/placebo (2.5 g/meal).
Study burden and risks
At the site of the catheter a hematoma could occur. This is the same for the
muscle biopsy. The muscle biopsy is performed by an experienced physician. The
incision made for obtaining the muscle biopsy will heal completely.
An ECG will be performed, during rest and exercise, before inclusion in the
study population, this to exclude cardiovascular problems.
The level of radiation emitted during a DEXA scan is very low, so this is
harmless.
The radiation from the CT scan is negligible because only one image is taken
and this on 0, 3 and 6 months of the intervention.
The ingested bolus of glucose is comparable with a commercial sport nutrition
drink. The ingested leucine/proteins are part of a normal diet as a precursor
for protein synthesis and impose no risk.
To minimize the risk for muscle soreness and/or muscle injuries, an experienced
invesitigator will supervise all exercise tests
Nieuwe Kanaal 9a
6709 PA Wageningen
Nederland
Nieuwe Kanaal 9a
6709 PA Wageningen
Nederland
Listed location countries
Age
Inclusion criteria
elderly men
older then 65 years of age
type 2 diabetes
Exclusion criteria
impaired renal or liver function, cardiac disease, hypertension, diabetes complications, and exogenous insulin therapy
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 |
|---|---|
| ClinicalTrials.gov | NCT00643773 |
| CCMO | NL22644.068.08 |