The effect of egg protein hydrolysate on arterial stiffness in overweight or moderately obese subjects with impaired glucose tolerance / diabetes type 2

Completed

Conditions: vaatflexibiliteit
arterial stiffness

Registration Number: NL-OMON39274

Lead Sponsor: niversiteit Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

- No allergy to chicken egg protein
- Age between 18 and 70 years
- Male and female
- Body Mass Index (BMI) between 25-35 kg/m2
- Diagnosed T2DM (use of antidiabetic drugs and/or a diabetic diet is allowed) or impaired glucose tolerance (IGT) defined as blood glucose > 7.0 mmol/L and < 11.0 mmol/L, two hours after ingesting 75 gram glucose in 250 mL water

Exclusion Criteria

- Active cardiovascular disease like congestive heart failure or recent (< 6 months) event (acute myocardial infarction, cerebral vascular incident)
- Severe medical conditions related to the intestine that might interfere with the study such as inflammatory bowel disease and celiac disease
- Use of insulin
- Use of medication such as RAAS blocking drugs, statins or drugs that change gastric motility or emptying
- Abuse of drugs or alcohol (> 21 units per week)
- Pregnant or breastfeeding women
- Current smoker
- Having donated blood at the blood bank within a period of 8 weeks prior to the start of the study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint will be the change (baseline versus 2 hours, and<br /><br>baseline versus 2 days) arterial stiffness measured as carotid-femoral pulse<br /><br>wave velocity after consumption of the egg protein hydrolysate. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary study endpoints will be the changes in plasma glucose and insulin<br /><br>concentrations and calculated HOMA-index, incretins, changes in serum lipids,<br /><br>changes in characteristics of the microcirculation as assessed by<br /><br>fundusphotography, changes in non-invasively assessed upper-arm blood pressure<br /><br>and Sphygmocor-derived central aortic systolic blood pressure and heart rate<br /><br>changes after the use of hydrolysate.</p><br>