Trial Outcomes & Findings for Diabetes and Lipid Accumulationand Heart Transplant (NCT NCT03546062)
NCT ID: NCT03546062
Last Updated: 2023-04-20
Results Overview
Authors will evaluate myocyte lipid accumulation as Oil Red-O positive biopsie after heart transplant at follow up.
Recruitment status
COMPLETED
Target enrollment
177 participants
Primary outcome timeframe
12 months.
Results posted on
2023-04-20
Participant Flow
Participant milestones
| Measure |
Diabetic Group With Metformin Therapy
Patients with DM for at least 6 months before HTX, with optimal glycemic control (HbA1c \<7.0), and metformin therapy without severe secondary end-organ disease (retinopathy, neuropathy or nephropathy) were included
|
Diabetic Group Without Metformin Therapy
Patients with DM for at least 6 months before HTX, with optimal glycemic control (HbA1c \<7.0), without metformin therapy and severe secondary end-organ disease (retinopathy, neuropathy or nephropathy) were included
|
Non-diabetic Group
Patients without DM for at least 6 months before HTX, with optimal glycemic control (HbA1c \<7.0), without end-organ disease (retinopathy, neuropathy or nephropathy) were included
|
|---|---|---|---|
|
Overall Study
STARTED
|
41
|
46
|
90
|
|
Overall Study
COMPLETED
|
35
|
41
|
82
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
8
|
Reasons for withdrawal
| Measure |
Diabetic Group With Metformin Therapy
Patients with DM for at least 6 months before HTX, with optimal glycemic control (HbA1c \<7.0), and metformin therapy without severe secondary end-organ disease (retinopathy, neuropathy or nephropathy) were included
|
Diabetic Group Without Metformin Therapy
Patients with DM for at least 6 months before HTX, with optimal glycemic control (HbA1c \<7.0), without metformin therapy and severe secondary end-organ disease (retinopathy, neuropathy or nephropathy) were included
|
Non-diabetic Group
Patients without DM for at least 6 months before HTX, with optimal glycemic control (HbA1c \<7.0), without end-organ disease (retinopathy, neuropathy or nephropathy) were included
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
6
|
5
|
8
|
Baseline Characteristics
Diabetes and Lipid Accumulationand Heart Transplant
Baseline characteristics by cohort
| Measure |
Diabetic Group Without Metformin Therapy
n=41 Participants
Authors will include a population of T2DM patients with advanced heart failure and treated by heart transplant. 41 patients recluted from January 2015
patients treated by HTx: From removed and frozen hearts, authors will conduct a tissue and molecular analysis of possible mechanisms T2DM linked.
|
Diabetic Group With Metformin Therapy
n=35 Participants
Authors will include a population of T2DM patients with advanced heart failure and treated by heart transplant in metformin therapy. 35 patients recluted from January 2015
patients treated by HTx: From removed and frozen hearts, authors will conduct a tissue and molecular analysis of possible mechanisms T2DM linked.
|
Non-diabetic Patients
n=82 Participants
Authors will include a population of non-diabetic patients with advanced heart failure treated by heart transplant. 82 patients recluted from January 2015
patients treated by HTx: From removed and frozen hearts, authors will conduct a tissue and molecular analysis of possible mechanisms T2DM linked.
|
Total
n=158 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 5.6 • n=99 Participants
|
50 years
STANDARD_DEVIATION 6.6 • n=107 Participants
|
52 years
STANDARD_DEVIATION 5.5 • n=206 Participants
|
51 years
STANDARD_DEVIATION 6.7 • n=7 Participants
|
|
Sex: Female, Male
SEX · Female
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
42 Participants
n=7 Participants
|
|
Sex: Female, Male
SEX · Male
|
30 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
116 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
158 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
158 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
Italy
|
41 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
158 Participants
n=7 Participants
|
|
ejection fraction
|
35 percent
STANDARD_DEVIATION 3 • n=99 Participants
|
37 percent
STANDARD_DEVIATION 2 • n=107 Participants
|
36 percent
STANDARD_DEVIATION 4 • n=206 Participants
|
36 percent
STANDARD_DEVIATION 3 • n=7 Participants
|
PRIMARY outcome
Timeframe: 12 months.Population: myocyte lipid accumulation as Oil Red-O positive biopsies
Authors will evaluate myocyte lipid accumulation as Oil Red-O positive biopsie after heart transplant at follow up.
Outcome measures
| Measure |
Diabetic Metformin Group
n=105 Endomyocardial Biopsies
Patients with DM for at least 6 months before HTX, with optimal glycemic control (HbA1c \<7.0), treated with metformin without severe secondary end-organ disease (retinopathy, neuropathy or nephropathy) were included
|
Diabetic Group Without Metformin Therapy
n=123 Endomyocardial Biopsies
Patients with DM for at least 6 months before HXT, with optimal glycemic control, that were not treated with metformin.
|
Non-diabetic Group
n=246 Endomyocardial Biopsies
Patients without diabetes
|
|---|---|---|---|
|
Myocyte Lipid Accumulation as Oil Red-O Positive Biopsie
|
54 Endomyocardial Biopsies
|
21 Endomyocardial Biopsies
|
0 Endomyocardial Biopsies
|
Adverse Events
Diabetic Metformin Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Diabetic Without Metformin Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non Diabetic Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Diabetic Metformin Group
n=35 participants at risk
Patients with DM for at least 6 months before HTX, with optimal glycemic control (HbA1c \<7.0), treated with metformin without severe secondary end-organ disease (retinopathy, neuropathy or nephropathy) were included
|
Diabetic Without Metformin Group
n=41 participants at risk
Patients with DM for at least 6 months before HTX, with optimal glycemic control (HbA1c \<7.0), that were not treated with metformin, without severe secondary end-organ disease (retinopathy, neuropathy or nephropathy) were included
|
Non Diabetic Patients
n=82 participants at risk
Patients without diabetes
|
|---|---|---|---|
|
Cardiac disorders
rejection
|
0.00%
0/35 • 12 month
heart rejection
|
0.00%
0/41 • 12 month
heart rejection
|
0.00%
0/82 • 12 month
heart rejection
|
Other adverse events
Adverse event data not reported
Additional Information
Raffaele Marfella
Università degli studi della Campania "luigi Vanvitelli"
Phone: +390815665110
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place