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Trial · Interventional

CompletedPhase 4Results postedRegistry data

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

Overview

Status
Completed
Phase
Phase 4
Enrollment
28 participants (actual)
Sponsor
Beth Israel Deaconess Medical Center · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
Mar 2012
Primary completion
May 2014
Completion
May 2014
First posted
26 Mar 2012 (estimated)
Last update posted
31 May 2017
Conditions
Diabetes · Effects of Liraglutide Administration on Brain Activity · Weight Loss · Hunger

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2012201320142015
  1. Ph 4

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

    NCT01562678

    Mar 2012 to May 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • LiraglutideDrug
  • PlaceboDrug

Arms2

  • Experimental

    Liraglutide

  • Placebo comparator

    Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change Between Highly Desirable vs. Less Desirable Food Cues in the Effect Size of Cortical Activation During Food Visualization

    Time frame · 18 days of Liraglutide or placebo treatment

    Registry description

    Effect size (region of interest z-scores, derived from z-maps of the brain) shown below is the difference in parietal cortex activation to highly desirable (high fat or high calorie, e.g. cakes, pies, fries) versus less desirable (low fat or low calorie, e.g. vegetables, fruits) food cues for each treatment condition (liraglutide or placebo) at the end of the treatment period.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 18 days of Liraglutide or placebo treatment

Change Between Highly Desirable vs. Less Desirable Food Cues in the Effect Size of Cortical Activation During Food Visualization

GroupValue (z-scores of activation in cortex)Spread
Liraglutide-0.420.27
Placebo0.530.37

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Liraglutide14 participants were randomized to receive Liraglutide and then were cross-overed to receive placebo and 14 participants were randomized to receive Placebo and then were cross-overed to receive Liraglutide–0 / 287 / 28
Placebo14 participants were randomized to receive Placebo and then were cross-overed to receive Liraglutide and 14 participants were randomized to receive Liraglutide and then were cross-overed to receive placebo–0 / 287 / 28

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2023

5 results

Early metabolomic, lipid and lipoprotein changes in response to medical and surgical therapeutic approaches to obesity.

Angelidi et al. 2023Metabolism: clinical and experimentalcited by 47

PMID 36375643DOI 10.1016/j.metabol.2022.155346PUB-36375643

Full text at the publisher5 results

Indexing hint: Randomized controlled trial · 2016

5 results

GLP-1 receptors exist in the parietal cortex, hypothalamus and medulla of human brains and the GLP-1 analogue liraglutide alters brain activity related to highly desirable food cues in individuals with diabetes: a crossover, randomised, placebo-controlled trial.

Farr et al. 2016Diabetologiacited by 231

PMID 26831302PMC4826792DOI 10.1007/s00125-016-3874-yPUB-26831302

Rights unknown5 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 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. Exclusion Criteria: 1. Uncontrolled diabetes (HbA1c\>8.9%, or FPG\>250 mg/dL) 2. Women who are breastfeeding, pregnant, or wanting to become pregnant. 3. Women using IUD 4. 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. 5. Moderate (creatinine clearance of 30-59 ml/min) and severe renal impairment (creatinine clearance below 30 ml/min) and end-stage renal disease 6. Moderate, or severe hepatic impairment 7. Hypersensitivity to the active substance or any of the excipients in liraglutide 8. History of diabetic ketoacidosis 9. Congestive heart failure 10. Inflammatory conditions like inflammatory bowel disease, Rheumatoid arthritis etc 11. Gastroparesis 12. Pancreatitis 13. Gallstones- as they may cause increased risk of pancreatitis 14. 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. 15. Untreated thyroid disease like hypothyroidism or hyperthyroidism 16. Subjects taking the following medications: warfarin, steroids (inhaled or systemic due to reduced hypoglycemic effect), and subjects on other hormones (LHRH analogs etc). 17. Subjects on any oral anti-diabetic agent except metformin 18. Personal or family history of MEN II or medullary thyroid cancer 19. 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.) 20. 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 21. Anxiety and/or claustrophobia 22. Uncontrolled cardiac impairment, circulatory impairment, or inability to perspire (poor thermoregulatory function) 23. Significant sensory or motor impairment 24. Epilepsy, particularly photo-sensitive epilepsy, which may place the individual at a higher risk for adverse events during fMRI scanning with visual stimulation 25. Subjects with neurological problems which may interfere with or complicate testing (e.g. presence of titubation) 26. Body weight above the limitation of the MRI scanning table (330lbs/150 Kg) or body dimensions that could difficult the performance of the scan. 27. Subjects who cannot adhere to the experimental protocol for any reason 28. Anemia with Hgb less than 10 29. Uncontrolled infectious diseases (e.g. HIV, hepatitis, chronic infections etc) 30. Any uncontrolled endocrine condition, e.g Cushing's, Acromegaly, etc 31. Any cancers or lymphoma 32. Eating disorders like anorexia, bulimia 33. Severe hypertriglyceridemia (triglycerides \>500 mg/dl) 34. Weight loss surgery or gastrectomy 35. Any changes in medications that affect brain function, e.g. anti-depressants, anti-psychotics, anti-anxiety, anti-seizure medications, antihypertensives etc (subjects should remain on same medication/ same dose during the time of the entire study). 36. Irregular periods, defined as cycle length less than 22 days or more than 40 days. 37. Any change in smoking status. 38. Vegetarians- as food images presented will include numerous non-vegetarian items and thus will not be appealing as high calorie food items.

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