The Effect of Postprandial Hyperglycemia on Arterial Stiffness in Patients with Type 2 Diabetes

• Conditions: Type 2 diabetes; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2010-018759-82-FI
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-28
• Last Update Posted: 13 May 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 89

Inclusion Criteria

Diabetic patients are eligible to be included in the study only if they meet all of the following criteria:
[1] Men 45 to 70 years of age.
[2] Are diagnosed with T2DM (according to the American Diabetes Association classification [American Diabetes Association 2006]) and on insulin therapy for at least 6 months.
[3] Have not smoked in the last 12 hours prior to the study.
[4] Have albuminuria but normal kidney function or normal UAER (UAER <20 µg/min or <30 mg/24h, respectively). Patients with or without albuminuria but normal kidney function will be matched for age and BMI.
[5] Patients have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests and examinations required by the protocol.
[6] Each patient must understand the nature of the study and must sign an ICD.

Healthy subjects are eligible to be included in the study only if they meet all of the following criteria:
[7] Men 45 to 70 years of age, matched for age and BMI, who have not smoked in the last 12 hours prior to the study.
[8] Normal glucose tolerance (according to the World Health Organization [WHO] criteria, i.e. fasting glucose <6,1 mmol/L and 2-hour glucose <7,8 mmol/L) and normal UAER (UAER between <20 µg/min in the overnight urine collection or <30 mg/24h in the 24 hour urine collection).
[9] Healthy subjects have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests and examinations required by the protocol.
[10] Each healthy subject must understand the nature of the study and must sign an ICD.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients/healthy subjects will be excluded from the study if they meet any of the following criteria:
[11] Have had a cardiovascular event (stroke, myocardial infarction [MI], coronary artery procedure [by-pass surgery or angioplasty], limb amputation due to ischemia, peripheral vascular disease) or coronary heart disease confirmed by exercise test or scintigraphy.
[12] Have arrhythmias.
[13] Have an acute infection.
[14] Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
[15] Are Lilly employees.
[16] Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off label use of a drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
[17] Are unwilling or unable to comply with the use of a data collection device to directly record data from the subject.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified