The Effect of Liraglutide on Dietary Lipid Induced Insulin Resistance in Humans

• Status: Active, not recruiting
• Trial end date: 2021-05-01
• Target enrollment: 0
• Participant gender: All

Summary

In this research study, investigators will test the effects of an approved medication for diabetes,Liraglutide, to reduce insulin resistance that develops from eating a diet high in saturated fats.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Phoenix VA Health Care System
• Collaborator: Novo Nordisk A/S
• Treatments: Insulin; Liraglutide

Criteria

Inclusion Criteria:

1. Age 40-75 years old

2. Body mass index (BMI) from 22 to 35 kg/m2

3. Normal glucose tolerance as determined by fasting blood glucose (< 100 mg/dl) and 75 gm glucose load (2 hr glucose <140 mg/dl)

4. Fasting triglyceride levels ≥ 75 mg/dl and <500 mg/dl

Exclusion Criteria:

1. Type 1 or 2 diabetes mellitus or a hemoglobin A1c value >6.5 mg/dl

2. Any diabetes medications in the past month, thiazolidinedione medications in the prior 3 months or prior regular use of insulin

3. Lactose intolerance or avoidance of dairy products

4. Creatinine > 2.0 mg/dl or other laboratory evidence of active disease, including hepatic enzyme elevation (AST or ALT) > 2.5 x normal and anemia (Hct < 35)

5. Known 'Nonalcoholic Fatty Liver Disease'

6. Malabsorption of fat or other nutrients, severe lactose intolerance or other significant gastrointestinal or pancreatic problems (including history of acute or chronic pancreatitis).

7. Recent history of nausea or vomiting

8. Acute bacterial or viral illness or evidence of other active infection in the past 4 weeks

9. Prior cardiovascular event, stable or unstable angina or other major illness in the past 6 months

10. Current regular use of anti-inflammatory medications or antioxidants in excess of a standard daily multi-vitamin, including over- the-counter medications and high dose salicylates (> 1 gm/ day)

11. Subjects receiving a lipid lowering medication must be on a stable dose for at least 6 weeks prior to participation.

12. Personal or family history of medullary thyroid carcinoma or in patients with multiple endocrine neoplasia 2

13. Ethanol consumption more than 4 oz day

14. Pregnancy, or lack of appropriate contraceptive use in premenopausal women (extremely rare in our older predominately male population)

15. Poorly controlled hypertension, systolic blood pressure (SBP) > 150 or diastolic blood pressure (DBP) > 90 on 2 or more occasions during screening visits. Subjects receiving blood pressure medication will be on a stable dosing for at least 6 weeks prior to participation.

16. BMI <22 and >35 kg/m2