Study S000930

Combined Effects of SGLT2 Inhibition and GLP-1 Receptor Agonism on Food Intake, Body Weight and Central Satiety and Reward Circuits in Obese T2DM Patients

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT03361098
Acronym: DECREASE
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE4
Masking: DOUBLE
Status: COMPLETED
Enrollment: 65
Start: 2017-09-18
Primary completion: 2019-11-25
Lead sponsor: Amsterdam UMC, location VUmc
Conditions: Type 2 Diabetes Mellitus; Obesity
Interventions: DRUG:Dapagliflozin 10mg; DRUG:Exenatide; OTHER:placebo exenatide; OTHER:placebo dapagliflozin
Results posted: FALSE
Individual participant data sharing: YES

Registered primary outcomes

Differences in neuronal activity in the central reward and satiety circuits in response to food-related stimuli by BOLD fMRI signal [at baseline, after 10 days and after 16 weeks]

Linked records (12)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0008399	Effects of Dapagliflozin and Combination Therapy With Exenatide on Food-Cue Induced Brain Activation in Patients With Type 2 Diabetes. van Ruiten CC, The Journal of clinical endocrinology and metabolism	2022	Randomized trial	PMID 35134184 DOI	cites ClinicalTrials.gov:NCT03361098; registry reference DERIVED:35134184
R0008648	Mechanisms underlying the blood pressure lowering effects of dapagliflozin, exenatide, and their combination in people with type 2 diabetes: a secondary analysis of a randomized trial. van Ruiten CC, Cardiovascular diabetology	2022	Randomized trial	PMID 35484607 DOI	cites ClinicalTrials.gov:NCT03361098; registry reference DERIVED:35484607
R0017701	GLP-1 and the kidney: from physiology to pharmacology and outcomes in diabetes. Muskiet MHA, Nature reviews. Nephrology	2017	Randomized trial	PMID 28869249 DOI	registry reference BACKGROUND:28869249
R0025222	Dapagliflozin once daily plus exenatide once weekly in obese adults without diabetes: Sustained reductions in body weight, glycaemia and blood pressure over 1 year. Lundkvist P, Diabetes, obesity & metabolism	2017	Randomized trial	PMID 28345814 DOI	registry reference BACKGROUND:28345814
R0021793	Exenatide once weekly plus dapagliflozin once daily versus exenatide or dapagliflozin alone in patients with type 2 diabetes inadequately controlled with metformin monotherapy (DURATION-8): a 28 week, multicentre, double-blind, phase 3, randomised controlled trial. Frías JP, The lancet. Diabetes & endocrinology	2016	Randomized trial	PMID 27651331 DOI	registry reference BACKGROUND:27651331
R0026455	Endogenous GLP1 and GLP1 analogue alter CNS responses to palatable food consumption. Ten Kulve JS, The Journal of endocrinology	2016	Randomized trial	PMID 26769912 DOI	registry reference BACKGROUND:26769912
R0026686	Decreased Hypothalamic Glucagon-Like Peptide-1 Receptor Expression in Type 2 Diabetes Patients. Ten Kulve JS, The Journal of clinical endocrinology and metabolism	2016	Preclinical	PMID 26672638 DOI	registry reference BACKGROUND:26672638
R0019403	Emotional eating is associated with increased brain responses to food-cues and reduced sensitivity to GLP-1 receptor activation. van Bloemendaal L, Obesity (Silver Spring, Md.)	2015	Randomized trial	PMID 26331843 DOI	registry reference BACKGROUND:26331843
R0023304	Brain reward-system activation in response to anticipation and consumption of palatable food is altered by glucagon-like peptide-1 receptor activation in humans. van Bloemendaal L, Diabetes, obesity & metabolism	2015	Other	PMID 26094857 DOI	registry reference BACKGROUND:26094857
R0028201	Endogenous GLP-1 mediates postprandial reductions in activation in central reward and satiety areas in patients with type 2 diabetes. ten Kulve JS, Diabetologia	2015	Randomized trial	PMID 26385462 DOI	registry reference BACKGROUND:26385462
R0017997	Effects of glucagon-like peptide 1 on appetite and body weight: focus on the CNS. van Bloemendaal L, The Journal of endocrinology	2014	Narrative review	PMID 24323912 DOI	registry reference BACKGROUND:24323912
R0020061	GLP-1 receptor activation modulates appetite- and reward-related brain areas in humans. van Bloemendaal L, Diabetes	2014	Randomized trial	PMID 25071023 DOI	registry reference BACKGROUND:25071023