Trial Outcomes & Findings for Effects of Incretins on Human Platelet Function (NCT NCT01408862)
NCT ID: NCT01408862
Last Updated: 2014-09-23
Results Overview
1.1 Measurement of GLP-1 and GIP receptors at the platelet RNA level by Real Time-PCR 1.2 GLP-1 and GIP receptors detection at the protein level: 1.2.1 Expression on platelet membrane by flow cytometry. 1.2.2 Detection in total platelet proteins by western-blot. Data of flow cytometry are provided below
COMPLETED
20 participants
Platelets drawn from a volunteer were evaluated 1 time (in 1-2 days)
2014-09-23
Participant Flow
Platelets from 20 healthy human subjects who were not taken any medication in the previous 10 days were studied during 18 month in our institution.
Participant milestones
| Measure |
Controls
20 healthy volunteers were asked to donor a 10-80 ml blood through a venous puncture
venous puncture: Blood for in vitro studies were drawn
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Overall Study
STARTED
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20
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Overall Study
COMPLETED
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20
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Incretins on Human Platelet Function
Baseline characteristics by cohort
| Measure |
Controls
n=20 Participants
Platelets from healthy human subjects who were not taken any medication in the previous 10 days were studied. Blood samples (30 ml) were drawn with i) ACD-C (9:1, v/v) (7 mmol/L citric acid, 93 mmol/L citrate, 139 mmol/L dextrose, pH 6.4) for gene expression and western blot studies; ii) with 1% EDTA for flow cytometry and iii) with 3.8% sodium citrate for functional studies. Blood samples were centrifuged at 150 g for 10 min to obtain platelet-rich plasma (PRP).
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Age, Continuous
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42 years
STANDARD_DEVIATION 10 • n=5 Participants
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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20 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
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Sex: Female, Male
Female
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10 Participants
n=5 Participants
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Sex: Female, Male
Male
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10 Participants
n=5 Participants
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Region of Enrollment
Argentina
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20 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Platelets drawn from a volunteer were evaluated 1 time (in 1-2 days)1.1 Measurement of GLP-1 and GIP receptors at the platelet RNA level by Real Time-PCR 1.2 GLP-1 and GIP receptors detection at the protein level: 1.2.1 Expression on platelet membrane by flow cytometry. 1.2.2 Detection in total platelet proteins by western-blot. Data of flow cytometry are provided below
Outcome measures
| Measure |
Controls
n=20 Participants
Flow cytometry studies In order to test the presence of GLP1 and GIP receptors on normal platelet membrane, indirect immunodetection was carried out in platelet samples from 20 normal donors.
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Expression of Glucagon Like Peptide -1 (GLP-1) and Gastric Inhibitory Peptide (GIP) Receptors in Normal Human Platelets
GIPR
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4.42 percentage of positive cells
Standard Deviation 1.70
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Expression of Glucagon Like Peptide -1 (GLP-1) and Gastric Inhibitory Peptide (GIP) Receptors in Normal Human Platelets
GLP1R
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3.73 percentage of positive cells
Standard Deviation 2.43
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PRIMARY outcome
Timeframe: Platelets drawn from a volunteer will be evaluated 1 time (in 1-2 days)Population: We assume that with 10 samples per condition divided in 5 categories (1 control plus 4 concentrations of GLP1 and GIP agonists) for a standardized difference of 0.5 between groups and a p=0.05, the statistical power would be higher than 90%. We used a similar design to test the effect of GLP1 and GIP agonists on platelet aggregants.
1 Direct effect of GLP-1-(7-36)NH2 and its metabolite (GLP-1-(9-36)NH2) and GIP agonist on platelet aggregation, with and without preincubation at different glucose concentrations. 2\. GLP-1-(7-36)NH2 and its metabolite (GLP-1-(9-36)NH2) and GIP agonist modulation (with and without 300 mg/dL glucose added to the media) of platelet activation and aggregation induced by classical platelet agonists such as ADP, collagen and bovine von Willebrand factor. Data points from various conditions were combined (averaged),
Outcome measures
| Measure |
Controls
n=20 Participants
Flow cytometry studies In order to test the presence of GLP1 and GIP receptors on normal platelet membrane, indirect immunodetection was carried out in platelet samples from 20 normal donors.
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Changes in Basal or Aggregant-induced Platelet Activation (With and Without Glucose Added to the Media, 200 mg/dl, 400 mg/dL) by GLP-1-(7-36)NH2 and Its Metabolite (GLP-1-(9-36)NH2)and a GIP Agonist at Different Concentrations.
GIP
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0 % of Inhibition
Standard Deviation 8
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Changes in Basal or Aggregant-induced Platelet Activation (With and Without Glucose Added to the Media, 200 mg/dl, 400 mg/dL) by GLP-1-(7-36)NH2 and Its Metabolite (GLP-1-(9-36)NH2)and a GIP Agonist at Different Concentrations.
GLP1
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0 % of Inhibition
Standard Deviation 10
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Adverse Events
Controls
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Carlos Jose Pirola
Institute of Medical Research (UBA-CONICET)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60