LIBRA

CompletedPhase NA

Effects of Glucagon Like Peptide-1(GLP-1) and Liraglutide on Brain Satiety and Reward Circuits and Feeding Behavior in Diabetes

Central Effects of Endogenous Glucagon Like Peptide-1 (GLP-1) and the GLP-1 Analog Liraglutide on Brain Satiety and Reward Circuits and Feeding Behavior in Diabetes

Lead sponsor

Amsterdam UMC, location VUmc

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Bariatric Surgery Candidate, Healthy volunteers, Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI ≤25•HbA1c 6.5-8.5%•Healthy volunteers

Primary endpoint

•Food-stimuli related neuronal activity in reward

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01363609

Org study IDDC2011LiBrain001

Timeline

Milestones

Study first posted2011-06-01estimated

Last update posted2015-02-18estimated

Study start2011-10 (month precision)

Primary completion2015-01actual (month precision)

Study completion2015-01actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Bariatric Surgery CandidateHealthy volunteersObesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•For the healthy, lean individuals:

•Age 18-65 years

•Women: post menopausal (excluding possible menstruation cycle effects)

•Body-mass index (BMI) of <25 kg/m2,

•Stable bodyweight (<5% reported change during the previous 3 months).

•Normal fasting and 2h post load glucose as ascertained during a 75-g oral glucose tolerance test (OGTT) (34)

•Right handed

For the obese T2DM individuals:

•Age 18-65 years

•Women: post menopausal (excluding possible menstruation cycle effects)

•BMI 25-40 kg/m2

•Stable bodyweight (<5% reported change during the previous 3 months).

•Diagnosed with T2DM > 3 months prior to screening

•HbA1C 6.5-8.5%

•Treatment with metformin at a stable dose for at least 3 months.

•Right handed

For the obese individuals scheduled for gastric bypass surgery:

•Age 18-65 years

•Women: preferably post menopausal (excluding possible menstruation cycle effects)

•Body-mass index (BMI) of >30 kg/m2,

•Stable bodyweight (<5% reported change during the previous 1 months).

•Normal or impaired fasting and 2h post load glucose as ascertained during a 75-g oral glucose tolerance test (OGTT) (defined as glucose fasting < 7.1 mmol/l and after OGTT t=120min < 11.0 mmol/l) (39)

•Right handed

Exclusion criteria

•GLP-1 based therapies, thiazolidinediones, sulphonylurea or insulin within 3 months before screening

•Weight-lowering agents within 3 months before screening.

•Congestive heart failure (NYHA II-IV)

•Chronic renal failure (glomerular filtration rate < 60 mL/min/1.73m2 per Modification of Diet in Renal Disease (MDRD))

•Liver disease

•History of gastrointestinal disorders (including gastropareses, pancreatitis and cholelithiasis)

•Neurological illness

•Malignancy

•Other type of bariatric surgery (Redo-GBP, sleeve, distal GBP, adj banding, Scopinaro)

•History of major heart disease

•History of major renal disease

•Pregnancy or breast feeding

•Implantable devices

•Substance abuse

•Addiction

•Contra-indication for MRI, such as claustrophobia or pacemaker

•Any psychiatric illness; including eating disorders and depression

•Chronic use of centrally acting agents or glucocorticoids within 2 weeks immediately prior to screening.

•Use of cytostatic or immune modulatory agents

•History or known allergy for acetaminophen.

•History of allergy for insulin analog

•History of allergy for liraglutide

•Participation in other studies

•Individuals who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry

•Individuals who are investigator site personnel, directly affiliated with the study, or are immediate family

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Patient-reported / QoL

Other clinical outcomes

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

GLP-1 analog treatment related changes in obese patients with type 2 diabetes in self-reported hunger, satiety, fullness