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Completed

NCT Number: NCT01159938

A Study of Postprandial Hyperglycemia in Participants With Type 2 Diabetes

This Study is looking at whether high blood glucose levels after a meal affect arterial stiffness more or less than low blood glucose levels, and whether certain cardiovascular markers influence the outcome of this.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

45 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Helsinki, 00014, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Are diagnosed with T2DM (according to the American Diabetes Association classification [American Diabetes Association 2006]) and on insulin therapy for at least 6 months.
  • Have not smoked in the last 12 hours prior to the study visit.
  • Have albuminuria but normal kidney function or normal UAER [UAER < 20 micrograms per minute (mcg/min) or < 30 milligrams/24 hours (mg/24h), respectively]. Participants with or without albuminuria but normal kidney function will be matched for age and body mass index (BMI).
  • Participants have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests and examinations required by the protocol.
  • Each participant must understand the nature of the study and must sign an informed consent document (ICD).

Healthy participants are eligible to be included in the study only if they meet all of the following criteria:

  • Healthy participants 45 to 70 years of age, matched for age and BMI, who have not smoked in the last 12 hours prior to the study.
  • Normal glucose tolerance and normal UAER (UAER between < 20 μg/min in the overnight urine collection or < 30 mg/24h in the 24-h urine collection).
  • Healthy participants have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests and examinations required by the protocol.
  • Each healthy participant must understand the nature of the study and must sign an ICD.

Exclusion criteria

Participants/healthy participants will be excluded from the study if they meet any of the following criteria:

  • 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.
  • Have arrhythmias.
  • Have an acute infection.
  • 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.
  • Are unwilling or unable to comply with the use of a data collection device to directly record data from the participant.

Treatment and study plan

Lispro

Drug

Dosage based on participants with type 2 diabetes mellitus (T2DM) normal morning insulin dose and energy content of participant's normal breakfast. Subcutaneous injection given on one occasion. Administered once on low post prandial day.

Other names: Humalog, LY275585

Primary outcomes

  1. Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 30 Minutes (Mins) Pre-Breakfast

    Time frame: 30 mins (pre-breakfast)

    The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.

  2. Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 60 Minutes (Mins) Post-Breakfast

    Time frame: 60 mins (post-breakfast)

    The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.

  3. Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 120 Minutes (Mins) Post-Breakfast

    Time frame: 120 mins (post-breakfast)

    The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.

  4. Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 180 Minutes (Mins) Post-Breakfast

    Time frame: 180 mins (post-breakfast)

    The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.

  5. Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 240 Minutes (Mins) Post-Breakfast

    Time frame: 240 mins (post-breakfast)

    The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.

Secondary outcomes

  1. Change in Pulse Wave Amplitude (PWA)

    Time frame: 30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)

    The PWA measured systemic arterial stiffness (augmentation index). PWA was reported as a percentage of systolic peak and calculated as the difference between second and first systolic peak in an ascending aortic pulse pressure waveform divided by the first systolic peak then multiplied by 100. The change in PWA from baseline [30-minute (min) pre-breakfast] is reported.

  2. Change in Peripheral Artery Tonometry (PAT)

    Time frame: 30 mins (pre-breakfast), 120 and 240 mins (post-breakfast)

    The PAT device is a pneumatic plethysmograph that applies uniform pressure to the surface of each finger tip and measures digital pulse amplitude. The PAT was reported as a percentage of pulse amplitude and expressed as the ratio of post deflation to baseline pulse amplitude in hyperemic finger divided by the same ratio in the contralateral finger that served as a control. The change in PAT from baseline [30-minute (min) pre-breakfast] is reported.

  3. Change in QT Interval on Electrocardiogram (ECG)

    Time frame: 30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)

    QT interval is a measure of time from the beginning of the QRS complex to the end of the T wave on an ECG during which contraction of the ventricles occurs. Changes in QT interval from baseline [30-minute (min) pre-breakfast] are reported.

  4. Change in Blood Glucose (BG)

    Time frame: 30 mins (pre-breakfast), 50, 110 ,170, and 230 mins (post-breakfast)

    Changes in BG from the baseline [30-minute (min) pre-breakfast] are reported.

  5. Change in Postprandial Pulse Wave Velocity (PWV)

    Time frame: 30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)

    The PWV measured arterial stiffness in the aortic and brachial arteries of healthy participants and T2DM participants. Changes in PWV from baseline [30-minute (min) pre-breakfast] are reported.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jul 12, 2010
Registry last updated
Apr 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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