Clinical trial NCT01159938: A Study of Postprandial Hyperglycemia in Participants With Type 2 Diabetes
Official title: The Effect of Postprandial Hyperglycemia on the Arterial Stiffness in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2010-07-12
Enrollment: 72
Sex: MALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 30 Minutes (Mins) Pre-Breakfast
timeFrame: 30 mins (pre-breakfast)
measure: Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 60 Minutes (Mins) Post-Breakfast
timeFrame: 60 mins (post-breakfast)
measure: Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 120 Minutes (Mins) Post-Breakfast
timeFrame: 120 mins (post-breakfast)
measure: Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 180 Minutes (Mins) Post-Breakfast
timeFrame: 180 mins (post-breakfast)
measure: Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 240 Minutes (Mins) Post-Breakfast
timeFrame: 240 mins (post-breakfast)
Secondary outcomes:
measure: Change in Pulse Wave Amplitude (PWA)
timeFrame: 30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)
measure: Change in Peripheral Artery Tonometry (PAT)
timeFrame: 30 mins (pre-breakfast), 120 and 240 mins (post-breakfast)
measure: Change in QT Interval on Electrocardiogram (ECG)
timeFrame: 30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)
measure: Change in Blood Glucose (BG)
timeFrame: 30 mins (pre-breakfast), 50, 110 ,170, and 230 mins (post-breakfast)
measure: Change in Postprandial Pulse Wave Velocity (PWV)
timeFrame: 30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Gordin D, Saraheimo M, Tuomikangas J, Soro-Paavonen A, Forsblom C, Paavonen K, Steckel-Hamann B, Harjutsalo V, Nicolaou L, Pavo I, Koivisto V, Groop PH. Insulin exposure mitigates the increase of arterial stiffness in patients with type 2 diabetes and albuminuria: an exploratory analysis. Acta Diabetol. 2019 Nov;56(11):1169-1175. doi: 10.1007/s00592-019-01351-4. Epub 2019 May 22.
citation: Gordin D, Saraheimo M, Tuomikangas J, Soro-Paavonen A, Forsblom C, Paavonen K, Steckel-Hamann B, Vandenhende F, Nicolaou L, Pavo I, Koivisto V, Groop PH. Influence of Postprandial Hyperglycemic Conditions on Arterial Stiffness in Patients With Type 2 Diabetes. J Clin Endocrinol Metab. 2016 Mar;101(3):1134-43. doi: 10.1210/jc.2015-3635. Epub 2016 Jan 5.
citation: Muka T, de Jonge EA, Kiefte-de Jong JC, Uitterlinden AG, Hofman A, Dehghan A, Zillikens MC, Franco OH, Rivadeneira F. The Influence of Serum Uric Acid on Bone Mineral Density, Hip Geometry, and Fracture Risk: The Rotterdam Study. J Clin Endocrinol Metab. 2016 Mar;101(3):1113-22. doi: 10.1210/jc.2015-2446. Epub 2015 Dec 18.