Effect of GLP-1 on Postprandial Lipid Metabolism
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ClinicalTrials.gov Identifier: NCT01760772 |
Recruitment Status : Unknown
Verified November 2012 by David Dalessio, University of Cincinnati.
Recruitment status was: Not yet recruiting
First Posted : January 4, 2013
Last Update Posted : January 4, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Heart Disease | Drug: Exendin-9 Drug: GLP-1 Other: saline | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 42 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Basic Science |
Official Title: | The Role of GLP-1 in Lipid Metabolism in Healthy Subjects and in Subjects After Bariatric Surgery |
Study Start Date : | February 2013 |
Estimated Primary Completion Date : | February 2015 |
Estimated Study Completion Date : | February 2015 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Saline
0.9% saline
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Other: saline
Constant infusion |
Experimental: Exendin-9 (Ex-9)
Bolus of Ex-9 (7,500 pmol/kg) followed by a continuous infusion at 750 pmol/kg/min
|
Drug: Exendin-9
Bolus of Ex-9 (7500 pmol/kg) over 1 minute followed by continuous infusion at 750 pmol/kg/min
Other Name: Synthetic exendin (9-39) injection |
Experimental: GLP-1
GLP-1 infusion at 0.3 pmol/kg/min
|
Drug: GLP-1
Constant infusion of GLP-1 at 0.3 pmol/kg/min
Other Name: 7-36 amide |
- Postprandial Lipids Levels and Apolipoprotein B (ApoB) Levels in plasma [ Time Frame: 2 years ]
Total and lipoprotein-associated triglyceride and cholesterol levels in baseline and postprandial plasma.
Total apolipoprotein B48 (ApoB48) and apolipoprotein B100 (ApoB100) levels in baseline and postprandial plasma.
- Plasma insulin and glucagon [ Time Frame: 2 years ]Plasma insulin and glucagon in the fasting and postprandial periods
- Plasma free fatty acid (FFA) and glucose levels [ Time Frame: 2 years ]Plasma FFA and glucose levels during the fasting and postprandial state
- Plasma d-xylose and acetaminophen levels [ Time Frame: 2 years ]Plasma d-xylose and acetaminophen levels as indices of gastric emptying

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Ages Eligible for Study: | 40 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760772
Contact: Michelle R Adams, PhD | 513-558-6920 | michelle.adams@uc.edu | |
Contact: David D'Alessio, MD | 513-558-6689 | DALESSD@UCMAIL.UC.EDU |
United States, Ohio | |
Veteran's Affairs Clinical Research Unit | |
Cincinnati, Ohio, United States, 45220 | |
Contact: Michelle R Adams, PhD 513-558-6920 michelle.adams@uc.edu | |
Principal Investigator: Michelle R Adams, PhD | |
Principal Investigator: David D'Alessio, MD |
Principal Investigator: | Michelle R Adams, PhD | University of Cincinnati | |
Principal Investigator: | David D'Alessio, MD | University of Cincinnati |
Responsible Party: | David Dalessio, Professor, University of Cincinnati |
ClinicalTrials.gov Identifier: | NCT01760772 |
Other Study ID Numbers: |
12-09-20-01 |
First Posted: | January 4, 2013 Key Record Dates |
Last Update Posted: | January 4, 2013 |
Last Verified: | November 2012 |
heart disease GLP-1 Exendin-9 postprandial lipids |
Heart Diseases Cardiovascular Diseases |