Liraglutide in Obesity and Diabetes: Identification of CNS Targets Using fMRI

Completed · Phase 4 · Has a placebo group

Conditions studied: Diabetes, Effects of Liraglutide Administration on Brain Activity, Weight Loss, Hunger

In brief

The main purpose of this study is to help us understand the effects of diabetes medication Liraglutide on weight loss and hunger. The investigators have already determined what the highest tolerated dose of Liraglutide is through earlier human research studies. Liraglutide was approved by the FDA in January 2010 for treatment of diabetes. The investigators will also study the following: 1. The impact of Liraglutide on brain responses to food 2. It's effect on physiological and mental performance 3. If its effect on the brain differs among obese and lean diabetic subjects.

Key facts

Study ID

NCT01562678

Run by

Beth Israel Deaconess Medical Center

People needed

28

Starts

2012-03-01

Expected to finish

2014-05-01

Last updated by the study team

2017-05-31

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects will be men and women between the ages of 18 and 65. The following table list inclusion criteria for each group (lean diabetic and obese diabetic). Subjects must meet either HbA1c or fasting plasma glucose (FPG) criteria.
• Lean diabetic:
• BMI: 18-25 kg/m2 HbA1c: < 8.9% Fasting plasma glucose: <250 mg/dL Other inclusion criteria: On dietary modification and/or metformin
• Obese diabetic:
• BMI: >27 kg/m2 HbA1c: < 8.9% Fasting plasma glucose: <250 mg/dL Other inclusion criteria: On dietary modification and/or metformin
• Additionally, women participants must use double barrier methods to prevent pregnancy (diaphragm with intravaginal spermicide, cervical cap, male or female condom with spermicide). If a woman suspects that she has become pregnant at any time or does not use one of the contraceptive methods recommended by the investigator, she must notify the study staff. If a woman becomes pregnant, she will be withdrawn from the study. The study staff will follow the progress of her pregnancy and the birth of her child.

You may not qualify if…

• Uncontrolled diabetes (HbA1c>8.9%, or FPG>250 mg/dL)
• Women who are breastfeeding, pregnant, or wanting to become pregnant.
• Women using IUD
• Any change in the dosage of hormonal contraceptive medications (birth control pills, implanon). Subjects should remain on same medication/ same dose during the time of the entire study.
• Moderate (creatinine clearance of 30-59 ml/min) and severe renal impairment (creatinine clearance below 30 ml/min) and end-stage renal disease
• Moderate, or severe hepatic impairment
• Hypersensitivity to the active substance or any of the excipients in liraglutide
• History of diabetic ketoacidosis
• Congestive heart failure
• Inflammatory conditions like inflammatory bowel disease, Rheumatoid arthritis etc
• Gastroparesis
• Pancreatitis
• Gallstones- as they may cause increased risk of pancreatitis
• Alcohol consumption- the maximum quantity for men is 140g-210g per week. For women, the range is 84g-140g per week or drinking as consuming no more than two drinks a day for men and one for women. Alcohol can cause increased risk of pancreatitis and hypoglycemia.
• Untreated thyroid disease like hypothyroidism or hyperthyroidism
• Subjects taking the following medications: warfarin, steroids (inhaled or systemic due to reduced hypoglycemic effect), and subjects on other hormones (LHRH analogs etc).
• Subjects on any oral anti-diabetic agent except metformin
• Personal or family history of MEN II or medullary thyroid cancer
• Subjects with any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g. cochlear implants, pacemakers, neuron or biostimulators, electronic infusion pumps, etc.)
• Subjects with any type of metallic implant that could potentially be displaced or damaged during MRI, such as aneurysm clips, metallic skull plates, surgical implants etc. or metal containing tattoos
• Anxiety and/or claustrophobia
• Uncontrolled cardiac impairment, circulatory impairment, or inability to perspire (poor thermoregulatory function)
• Significant sensory or motor impairment
• Epilepsy, particularly photo-sensitive epilepsy, which may place the individual at a higher risk for adverse events during fMRI scanning with visual stimulation
• Subjects with neurological problems which may interfere with or complicate testing (e.g. presence of titubation)

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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