The fate of incomplete amino acid metabolism in type 2 diabetes

Completed

Conditions: diabetes mellitus type 2
sugar disease
10018424
10037008

Registration Number: NL-OMON43574

Lead Sponsor: niversiteit Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

Overall
* Male en postmenopausal females
* Age 45-70 years
* Body mass index (BMI) < 35 and > 27 kg/m2
* Stable dietary habits (no weight loss/gain >5 kg in the last 3 months)
* Stable physical activity levels for at least 6 months
* Control participants without type 2 diabetes should be normal glucose tolerant (OGTT with fasting plasma glucose <6.1 mmol/l (<110 mg/dl) and 2h glucose of <7.8 mmol/l (<140 mg/dl))
* FDR should have a at least 1 family member with type 2 diabetes (father, mother, sister or brother);Type 2 diabetic patients
* Non-insulin dependent type 2 diabetic patients, diagnosed with type 2 diabetes for at least 2 years using sulphonylurea- or metformin therapy for at least six months with a constant dose for at least two months
* Type 2 diabetic patients should have a HbA1c level <8.5%
* Type 2 diabetic patients will be included when having no active diabetes-related co-morbidities like cardiovascular diseases, diabetic foot, polyneuropathy, retinopathy.

Exclusion Criteria

- participants will be excluded when being diagnosed with active cardiovascular disease, diabetic foot, polyneuropathy, retinopathy
- participants will be excluded when having uncontrolled hypertension
- participants following a vegetarian diet or having an allergy against soya
- participants with contra-indication for MRI

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study objectives are:<br /><br>i) to determine whether T2DM and FDR have lower rate of leucine oxidation (umol<br /><br>kg-1 min-1) in muscle<br /><br>ii) to evaluate whether altered leucine oxidation is associated with whole body<br /><br>and hepatic insulin sensitivity (umol kg-1 min-1) </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study objectives are:<br /><br>i) to evaluate whether altered leucine oxidation is associated with<br /><br>mitochondrial function (pmol/mg/s)<br /><br>ii) to evaluate whether altered leucine oxidation is associated with the amount<br /><br>of liver fat (%)</p><br>