- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01159938
A Study of Postprandial Hyperglycemia in Participants With Type 2 Diabetes
21. Februar 2014 aktualisiert von: Eli Lilly and Company
The Effect of Postprandial Hyperglycemia on the Arterial Stiffness in Patients 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
72
Phase
- Phase 4
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Helsinki, Finnland, 00014
- 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.
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
45 Jahre bis 70 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Männlich
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: T2DM, albuminuria but normal kidney function
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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.
Andere Namen:
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Kein Eingriff: Healthy participants
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Experimental: T2DM, normal urinary albumin excretion rate (UAER)
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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.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 30 Minutes (Mins) Pre-Breakfast
Zeitfenster: 30 mins (pre-breakfast)
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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.
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30 mins (pre-breakfast)
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Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 60 Minutes (Mins) Post-Breakfast
Zeitfenster: 60 mins (post-breakfast)
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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.
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60 mins (post-breakfast)
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Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 120 Minutes (Mins) Post-Breakfast
Zeitfenster: 120 mins (post-breakfast)
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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.
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120 mins (post-breakfast)
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Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 180 Minutes (Mins) Post-Breakfast
Zeitfenster: 180 mins (post-breakfast)
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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.
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180 mins (post-breakfast)
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Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 240 Minutes (Mins) Post-Breakfast
Zeitfenster: 240 mins (post-breakfast)
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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.
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240 mins (post-breakfast)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Change in Pulse Wave Amplitude (PWA)
Zeitfenster: 30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)
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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.
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30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)
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Change in Peripheral Artery Tonometry (PAT)
Zeitfenster: 30 mins (pre-breakfast), 120 and 240 mins (post-breakfast)
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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.
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30 mins (pre-breakfast), 120 and 240 mins (post-breakfast)
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Change in QT Interval on Electrocardiogram (ECG)
Zeitfenster: 30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)
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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.
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30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)
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Change in Blood Glucose (BG)
Zeitfenster: 30 mins (pre-breakfast), 50, 110 ,170, and 230 mins (post-breakfast)
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Changes in BG from the baseline [30-minute (min) pre-breakfast] are reported.
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30 mins (pre-breakfast), 50, 110 ,170, and 230 mins (post-breakfast)
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Change in Postprandial Pulse Wave Velocity (PWV)
Zeitfenster: 30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)
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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.
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30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Studienleiter: 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), Eli Lilly and Company
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
- 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.
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Oktober 2010
Primärer Abschluss (Tatsächlich)
1. Februar 2013
Studienabschluss (Tatsächlich)
1. Februar 2013
Studienanmeldedaten
Zuerst eingereicht
17. Juni 2010
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
8. Juli 2010
Zuerst gepostet (Schätzen)
12. Juli 2010
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
3. April 2014
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
21. Februar 2014
Zuletzt verifiziert
1. Februar 2014
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 13087
- F3Z-EW-IOPT (Andere Kennung: Eli Lilly and Company)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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