Obesity, Overweight, Type 2 Diabetes
Conditions
Keywords
Epicardial fat, Type 2 diabetes, Obesity, GLP-1 analogs
Brief summary
The purpose of this research study is to learn about the effect of Liraglutide, (Victoza®), on the fat surrounding the heart.Excessive amount of the fat around the heart is common in people with type 2 diabetes and can be associated with poor sugar control. Liraglutide is an injectable prescription medicine that can improve blood sugar control in adults with type 2 diabetes.
Interventions
DRUGLiraglutide
Liraglutide (Victoza) is an acylated analogue of glucagon-like peptide-1 (GLP-1) indicated for the treatment of type 2 diabetes mellitus• L-group will be started and dose-escalated to 1.8mg sc once daily according to below schedule: Liraglutide will be administered with a starting dose of 0.6 mg (after a least one week) and subsequent increments to 1.2 mg (after a least one week) and to 1.8 mg (after at least a week on 1.2 mg). L-group subjects will need to achieve the final dose of 1.8 mg by at least three weeks from the starting dose. Subjects who would not be able to achieve the dose of 1.8 mg (due to potential side effects) will be advised to lower the dose to 1.2 mg. Metformin regimen will be continued. .
DRUGMetformin
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes, as defined by ADA criteria * HbA1c \< 8% measured at least 1 month prior to this study * BMI ≥27 kg/m2 * Pre-treatment with Metformin * Age \> 18 and \< 65 years old
Exclusion criteria
* • Known contra-indications to Liraglutide, such as previous history of pancreatitis or medullary thyroid carcinoma, personal or family history of MEN, in accordance with risks and safety information included in the latest updated Prescribing Information for Victoza® * Type 1 diabetes, as defined by American Diabetes Association (ADA) criteria * Insulin dependent or treated type 2 diabetes * Current use of other injectable incretins * History of diabetes ketoacidosis * Advanced Chronic Kidney Disease, as defined by Glomerular Filtration Rate (GFR) \< 30 mL/min/1.73m2 * Clinical signs or symptoms of New York Heart Association (NYHA) class III-IV heart failure * Clinical or laboratory evidences of chronic active liver diseases * Acute or chronic infective diseases * Cancer or chemotherapy * Current use of systemic corticosteroids or in the 3 months prior this study * Known or suspected allergy to Liraglutide, excipients, or related products * Pregnant, breast-feeding or the intention of becoming pregnant * Females of childbearing potential who are not using adequate contraceptive methods
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Echocardiographic Epicardial Fat Thickness | 6 months | Echocardiographic epicardial fat thickness is an non invasive, inexpensive, reproducible and direct measure of visceral fat. In fact, epicardial fat strongly reflects the intra-abdominal and intra-myocardial fat accumulation as measured by magnetic resonance imaging procedures. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Liraglutide • L-group will be started and dose-escalated to 1.8mg sc once daily according to below schedule: Liraglutide will be administered with a starting dose of 0.6 mg (after a least one week) and subsequent increments to 1.2 mg (after a least one week) and to 1.8 mg (after at least a week on 1.2 mg). L-group subjects will need to achieve the final dose of 1.8 mg by at least three weeks from the starting dose. Subjects who would not be able to achieve the dose of 1.8 mg (due to potential side effects) will be advised to lower the dose to 1.2 mg. Metformin regimen will be continued. | 55 |
| Metformin M-group will be treated with Metformin for the duration of the study. Metformin (from 500 mg twice daily to a maximum of 1000 mg twice daily) regimen will be continued to achieve fasting glucose between 80 and 140 mg/dl
Metformin | 45 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 4 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Total | Liraglutide | Metformin |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 100 Participants | 55 Participants | 45 Participants |
| Age, Continuous | 50.8 years STANDARD_DEVIATION 10 | 50 years STANDARD_DEVIATION 10 | 52 years STANDARD_DEVIATION 10 |
| Body Mass Index (BMI) | 35.2 kg/m2 STANDARD_DEVIATION 6 | 37.8 kg/m2 STANDARD_DEVIATION 7 | 32.6 kg/m2 STANDARD_DEVIATION 6 |
| Epicardial adipose tissue Thickness (EAT) | 8.75 mm STANDARD_DEVIATION 1.9 | 9.6 mm STANDARD_DEVIATION 2 | 7.4 mm STANDARD_DEVIATION 1.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 38 Participants | 21 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 62 Participants | 34 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| HemoglobinA1c (HbA1c) | 6.52 % STANDARD_DEVIATION 0.6 | 6.6 % STANDARD_DEVIATION 0.8 | 6.4 % STANDARD_DEVIATION 0.6 |
| Region of Enrollment United States | 100 participants | 55 participants | 45 participants |
| Sex: Female, Male Female | 61 Participants | 33 Participants | 28 Participants |
| Sex: Female, Male Male | 39 Participants | 22 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 45 |
| other Total, other adverse events | 16 / 55 | 12 / 45 |
| serious Total, serious adverse events | 0 / 55 | 0 / 45 |
Outcome results
Primary
Echocardiographic Epicardial Fat Thickness
Echocardiographic epicardial fat thickness is an non invasive, inexpensive, reproducible and direct measure of visceral fat. In fact, epicardial fat strongly reflects the intra-abdominal and intra-myocardial fat accumulation as measured by magnetic resonance imaging procedures.
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide | Echocardiographic Epicardial Fat Thickness | Baseline | 9.6 mm | Standard Deviation 2 |
| Liraglutide | Echocardiographic Epicardial Fat Thickness | 3-month | 6.8 mm | Standard Deviation 1.5 |
| Liraglutide | Echocardiographic Epicardial Fat Thickness | 6-month | 6.2 mm | Standard Deviation 1.5 |
| Metformin | Echocardiographic Epicardial Fat Thickness | Baseline | 7.4 mm | Standard Deviation 1.6 |
| Metformin | Echocardiographic Epicardial Fat Thickness | 3-month | 7.5 mm | Standard Deviation 1.5 |
| Metformin | Echocardiographic Epicardial Fat Thickness | 6-month | 6.9 mm | Standard Deviation 1.5 |