Effect of GLP-1 on Postprandial Lipid Metabolism
Status unconfirmed · Not applicable
Conditions studied: Heart Disease
In brief
Individuals with obesity have an increased risk for heart disease and diabetes. There are current drugs on the market that target the hormone, Glucagon like peptide-1 (GLP-1) to treat diabetes. The investigators want to determine if targeting this hormone will also help people with high cholesterol and triglycerides. In this study, the investigators are looking at the role of GLP-1 in healthy subjects and subjects that have had bariatric surgery.
Key facts
- Study ID
- NCT01760772
- Run by
- David Dalessio
- People needed
- 42
- Starts
- 2013-02-01
- Expected to finish
- 2015-02-01
- Last updated by the study team
- 2013-01-04
Who can join
Age: 40 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Aim 1: Healthy, normolipemic men and postmenopausal women; aged 40-60 years; BMI between 25-35
- Aim 2: Men and postmenopausal women after successful vertical sleeve gastrectomy (VSG) surgery and age- and weight-matched non-surgical control men and postmenopausal women; ages between 40-6- years; BMI between 28-35; steady weight for at least 3 months prior to study
You may not qualify if…
- Exclusion Criteria for Aim 1:
- History or clinical evidence of impaired fasting glucose or diabetes mellitus, myocardial infarction or symptoms of congestive heart failure, history or active liver or renal disease, calculated glomerular filtration rate < 60 mL/min).
- History of extreme dyslipidemia (i.e. familial hypercholesterolemia) or Cardiovascular disease (CVD).
- Fasting plasma total cholesterol > 200 mg/dL and fasting plasma TGs > 150 mg/dL.
- Surgery within 6 months.
- Pregnancy or lactation.
- Anemia defined as hematocrit < 33%.
- History of cancer or anorexia nervosa or GI disorders.
- Use of medications that alter insulin sensitivity (i.e. niacin, glucocorticoids, metformin) or lipid metabolism (i.e. statin, niacin, fibrate, ezetimibe).
- Plasma HbA1c > 6.0.
- Fasting glucose > 110 mg/dL
- Electrocardiogram (ECG) abnormalities: evidence of ischemia or arrhythmia.
- Exclusion Criteria for Aim 2:
- History of CVD.
- Fasting plasma total cholesterol > 250 mg/dL and fasting plasma TGs > 300 mg/dL.
- Surgical intervention within 6 months.
- Anemia defined as hematocrit < 33%.
- History of cancer or anorexia nervosa or other major GI disease or surgery.
- Use of medications that alter insulin sensitivity (i.e. niacin, glucocorticoids, metformin) or lipid metabolism (i.e. statin, ezetimibe).
- HbA1c > 6.0.
- Fasting glucose > 110 mg/dL
- Electrocardiogram (ECG) abnormalities: evidence of ischemia or arrhythmia.
- Significant renal, hepatic or pulmonary disease.
Where it is running
- Veteran's Affairs Clinical Research Unit — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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