Trial Outcomes & Findings for Defective Atypical Protein Kinase C (PKC) Activation in Diabetes and Metabolic Syndrome (NCT NCT00690755)
NCT ID: NCT00690755
Last Updated: 2016-05-19
Results Overview
All muscle samples obtained by 9/30/07, final date for examination of samples 9/30/08 Muscle dependent ability to diminish blood glucose levels during insulin treatment.
Recruitment status
COMPLETED
Target enrollment
157 participants
Primary outcome timeframe
PKC-zeta mRNA levels and aPKC activity in muscle evaluated 40 minutes post-insulin treatment
Results posted on
2016-05-19
Participant Flow
Participant milestones
| Measure |
Group 1
Type 2 diabetic
|
Group 2
Type 1 diabetic
|
Group 3
Control (non-diabetic)
|
Group 4
Non-diabetic overweight
|
Group 5
Non-diabetic and Type 2 diabetic
|
Group 6
Impaired glucose tolerance (IGT)
|
Group 7
Non-diabetic treated with Metformin
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
0
|
97
|
20
|
0
|
10
|
0
|
|
Overall Study
COMPLETED
|
28
|
0
|
51
|
15
|
0
|
6
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
46
|
5
|
0
|
4
|
0
|
Reasons for withdrawal
| Measure |
Group 1
Type 2 diabetic
|
Group 2
Type 1 diabetic
|
Group 3
Control (non-diabetic)
|
Group 4
Non-diabetic overweight
|
Group 5
Non-diabetic and Type 2 diabetic
|
Group 6
Impaired glucose tolerance (IGT)
|
Group 7
Non-diabetic treated with Metformin
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
2
|
0
|
46
|
5
|
0
|
4
|
0
|
Baseline Characteristics
Defective Atypical Protein Kinase C (PKC) Activation in Diabetes and Metabolic Syndrome
Baseline characteristics by cohort
| Measure |
Group 1
n=28 Participants
Type 2 diabetic
|
Group 2
Type 1 Diabetic
|
Group 3
n=51 Participants
Control (non-diabetic)
|
Group 4
n=15 Participants
Non-Diabetic Overweight
|
Group 5
Non-Diabetic and Type 2 Diabetic subjected to exercise study
|
Group 6
n=6 Participants
Impaired glucose tolerance (IGT)
|
Group 7
Non-Diabetic treated with Metformin
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 1 • n=99 Participants
|
—
|
47 years
STANDARD_DEVIATION 3 • n=206 Participants
|
51 years
STANDARD_DEVIATION 3 • n=7 Participants
|
—
|
43 years
STANDARD_DEVIATION 3 • n=30 Participants
|
—
|
47 years
STANDARD_DEVIATION 4 • n=6 Participants
|
|
Gender
Female
|
6 participants
n=99 Participants
|
—
|
18 participants
n=206 Participants
|
10 participants
n=7 Participants
|
—
|
3 participants
n=30 Participants
|
—
|
37 participants
n=6 Participants
|
|
Gender
Male
|
22 participants
n=99 Participants
|
—
|
33 participants
n=206 Participants
|
5 participants
n=7 Participants
|
—
|
3 participants
n=30 Participants
|
—
|
63 participants
n=6 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=99 Participants
|
—
|
51 participants
n=206 Participants
|
15 participants
n=7 Participants
|
—
|
6 participants
n=30 Participants
|
—
|
100 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: PKC-zeta mRNA levels and aPKC activity in muscle evaluated 40 minutes post-insulin treatmentPopulation: PKC-zeta mRNA and aPKC activity in vastus lateralis skeletal muscle was measured by analysis of gene expression levels of PKC and measuring them in relative amounts in comparison to control subjects.
All muscle samples obtained by 9/30/07, final date for examination of samples 9/30/08 Muscle dependent ability to diminish blood glucose levels during insulin treatment.
Outcome measures
| Measure |
Group 1
n=28 Participants
Type 2 diabetic
|
Group 2
Type 1 diabetic
|
Group 3
n=51 Participants
Control (non-diabetic)
|
Group 4
n=15 Participants
Non-diabetic overweight
|
Group 5
Non-diabetic and Type 2 diabetic
|
Group 6
n=6 Participants
Impaired glucose tolerance (IGT)
|
Group 7
Non-diabetic treated with Metformin
|
|---|---|---|---|---|---|---|---|
|
Alterations in PKC-zeta mRNA in Vastus Lateralis Skeletal Muscles
|
1.76 arbitrary units/ng rRNA
Standard Error 0.088
|
—
|
3.58 arbitrary units/ng rRNA
Standard Error 0.179
|
2.14 arbitrary units/ng rRNA
Standard Error 0.107
|
—
|
2.22 arbitrary units/ng rRNA
Standard Error 0.110
|
—
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 5
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 6
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 7
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1
n=30 participants at risk
Diabetics
|
Group 2
Type 1 diabetes
|
Group 3
n=51 participants at risk；n=97 participants at risk
Control (non-diabetic)
|
Group 4
n=15 participants at risk；n=20 participants at risk
Non-diabetic overweight
|
Group 5
Non-diabetic and Type 2 diabetic
|
Group 6
n=6 participants at risk；n=10 participants at risk
Impaired glucose tolerance (IGT)
|
Group 7
Non-diabetic treated with Metformin
|
|---|---|---|---|---|---|---|---|
|
General disorders
Syncopal event
|
3.3%
1/30 • Number of events 1
|
—
0/0
|
0.00%
0/51
|
0.00%
0/15
|
—
0/0
|
0.00%
0/6
|
—
0/0
|
|
Cardiac disorders
Chest pain
|
3.3%
1/30 • Number of events 1
|
—
0/0
|
0.00%
0/51
|
0.00%
0/15
|
—
0/0
|
0.00%
0/6
|
—
0/0
|
Additional Information
Robert Farese, MD
James A. Haley VA Research Department
Phone: 813-972-2000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place