Summary of Study ST001515

This data is available at the NIH Common Fund's National Metabolomics Data Repository (NMDR) website, the Metabolomics Workbench, https://www.metabolomicsworkbench.org, where it has been assigned Project ID PR001022. The data can be accessed directly via it's Project DOI: 10.21228/M8KT26 This work is supported by NIH grant, U2C- DK119886.

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Study ID	ST001515
Study Title	A Metabolomic Signature of Glucagon Action in Healthy Individuals with Overweight/Obesity Humans
Study Summary	Objective: We sought to identify the circulating metabolites that would serve as markers of glucagon action. Design: In this study, we performed a continuous 72-hour glucagon infusion in healthy individuals with overweight/obesity. Participants were randomized to either glucagon (12.5 ng/kg/min) (GCG 12.5) or glucagon (25 ng/kg/min) GCG 25 or a placebo control were included. A comprehensive metabolomics analysis was then performed from plasma isolated at several time points during the infusion to identify markers of glucagon activity.
Institute	Translational Research Institute- AdventHealth Orlando
Last Name	Whytock
First Name	Katie
Address	301 E Princeton St, Orlando, FL, 32804
Email	Katie.Whytock@adventhealth.com
Phone	321-945-9982
Submit Date	2020-10-26
Num Groups	3
Total Subjects	33
Raw Data Available	Yes
Analysis Type Detail	LC-MS
Release Date	2020-12-01
Release Version	1

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Project:

Project ID:	PR001022
Project DOI:	doi: 10.21228/M8KT26
Project Title:	Effects of glucagon infusion on plasma metabolome in individuals with overweight/obesity
Project Summary:	Objective: We sought to identify the circulating metabolites that would serve as markers of glucagon action. Design: In this study, we performed a continuous 72-hour glucagon infusion in healthy individuals with overweight/obesity. Participants were randomized to either glucagon (12.5 ng/kg/min) (GCG 12.5) or glucagon (25 ng/kg/min) GCG 25 or a placebo control were included. A comprehensive metabolomics analysis was then performed from plasma isolated at several time points during the infusion to identify markers of glucagon activity.
Institute:	Translational Research Institute- AdventHealth Orlando
Last Name:	Whytock
First Name:	Katie
Address:	301 E Princeton St, FL, USA, 32804
Email:	Katie.Whytock@adventhealth.com
Phone:	3219459982
Funding Source:	Sanofi

Subject:

Subject ID:	SU001589
Subject Type:	Human
Subject Species:	Homo sapiens
Taxonomy ID:	9606
Species Group:	Mammals

Factors:

Subject type: Human; Subject species: Homo sapiens (Factor headings shown in green)

mb_sample_id	local_sample_id	Group	TIMEPOINT
SA127238	FLHP-00174-01	High-Dose	-0.5HR
SA127239	FLHP-00028-01	High-Dose	-0.5HR
SA127240	FLHP-00062-01	High-Dose	-0.5HR
SA127241	FLHP-00111-01	High-Dose	-0.5HR
SA127242	FLHP-00012-01	High-Dose	-0.5HR
SA127243	FLHP-00090-01	High-Dose	-0.5HR
SA127244	FLHP-00057-01	High-Dose	-0.5HR
SA127245	FLHP-00037-01	High-Dose	-0.5HR
SA127246	FLHP-00151-01	High-Dose	-0.5HR
SA127247	FLHP-00006-01	High-Dose	-0.5HR
SA127197	FLHP-00055-01	High-Dose	+23HR POST INFUSION
SA127198	FLHP-00016-01	High-Dose	+23HR POST INFUSION
SA127199	FLHP-00186-01	High-Dose	+23HR POST INFUSION
SA127200	FLHP-00061-01	High-Dose	+23HR POST INFUSION
SA127201	FLHP-00148-01	High-Dose	+23HR POST INFUSION
SA127202	FLHP-00025-01	High-Dose	+23HR POST INFUSION
SA127203	FLHP-00039-01	High-Dose	+23HR POST INFUSION
SA127204	FLHP-00088-01	High-Dose	+23HR POST INFUSION
SA127205	FLHP-00110-01	High-Dose	+23HR POST INFUSION
SA127206	FLHP-00011-01	High-Dose	+23HR POST INFUSION
SA127207	FLHP-00040-01	High-Dose	+47HR POST INFUSION
SA127208	FLHP-00171-01	High-Dose	+47HR POST INFUSION
SA127209	FLHP-00027-01	High-Dose	+47HR POST INFUSION
SA127210	FLHP-00015-01	High-Dose	+47HR POST INFUSION
SA127211	FLHP-00056-01	High-Dose	+47HR POST INFUSION
SA127212	FLHP-00184-01	High-Dose	+47HR POST INFUSION
SA127213	FLHP-00086-01	High-Dose	+47HR POST INFUSION
SA127214	FLHP-00152-01	High-Dose	+47HR POST INFUSION
SA127215	FLHP-00010-01	High-Dose	+47HR POST INFUSION
SA127216	FLHP-00109-01	High-Dose	+47HR POST INFUSION
SA127217	FLHP-00054-01	High-Dose	+4HR POST INFUSION
SA127218	FLHP-00150-01	High-Dose	+4HR POST INFUSION
SA127219	FLHP-00036-01	High-Dose	+4HR POST INFUSION
SA127220	FLHP-00173-01	High-Dose	+4HR POST INFUSION
SA127221	FLHP-00024-01	High-Dose	+4HR POST INFUSION
SA127222	FLHP-00087-01	High-Dose	+4HR POST INFUSION
SA127223	FLHP-00014-01	High-Dose	+4HR POST INFUSION
SA127224	FLHP-00008-01	High-Dose	+4HR POST INFUSION
SA127225	FLHP-00113-01	High-Dose	+4HR POST INFUSION
SA127226	FLHP-00183-01	High-Dose	+4HR POST INFUSION
SA127227	FLHP-00063-01	High-Dose	+4HR POST INFUSION
SA127228	FLHP-00147-01	High-Dose	+71HR POST INFUSION
SA127229	FLHP-00058-01	High-Dose	+71HR POST INFUSION
SA127230	FLHP-00112-01	High-Dose	+71HR POST INFUSION
SA127231	FLHP-00060-01	High-Dose	+71HR POST INFUSION
SA127232	FLHP-00172-01	High-Dose	+71HR POST INFUSION
SA127233	FLHP-00038-01	High-Dose	+71HR POST INFUSION
SA127234	FLHP-00023-01	High-Dose	+71HR POST INFUSION
SA127235	FLHP-00182-01	High-Dose	+71HR POST INFUSION
SA127236	FLHP-00089-01	High-Dose	+71HR POST INFUSION
SA127237	FLHP-00009-01	High-Dose	+71HR POST INFUSION
SA127248	FLHP-00053-01	High-Dose	BASELINE
SA127249	FLHP-00013-01	High-Dose	BASELINE
SA127250	FLHP-00114-01	High-Dose	BASELINE
SA127251	FLHP-00007-01	High-Dose	BASELINE
SA127252	FLHP-00185-01	High-Dose	BASELINE
SA127253	FLHP-00035-01	High-Dose	BASELINE
SA127254	FLHP-00175-01	High-Dose	BASELINE
SA127255	FLHP-00059-01	High-Dose	BASELINE
SA127256	FLHP-00026-01	High-Dose	BASELINE
SA127257	FLHP-00091-01	High-Dose	BASELINE
SA127258	FLHP-00149-01	High-Dose	BASELINE
SA127304	FLHP-00133-01	Low-Dose	-0.5HR
SA127305	FLHP-00146-01	Low-Dose	-0.5HR
SA127306	FLHP-00190-01	Low-Dose	-0.5HR
SA127307	FLHP-00181-01	Low-Dose	-0.5HR
SA127308	FLHP-00034-01	Low-Dose	-0.5HR
SA127309	FLHP-00156-01	Low-Dose	-0.5HR
SA127310	FLHP-00139-01	Low-Dose	-0.5HR
SA127311	FLHP-00066-01	Low-Dose	-0.5HR
SA127312	FLHP-00115-01	Low-Dose	-0.5HR
SA127313	FLHP-00121-01	Low-Dose	-0.5HR
SA127314	FLHP-00101-01	Low-Dose	-0.5HR
SA127315	FLHP-00078-01	Low-Dose	-0.5HR
SA127259	FLHP-00118-01	Low-Dose	+23HR POST INFUSION
SA127260	FLHP-00100-01	Low-Dose	+23HR POST INFUSION
SA127261	FLHP-00077-01	Low-Dose	+23HR POST INFUSION
SA127262	FLHP-00153-01	Low-Dose	+23HR POST INFUSION
SA127263	FLHP-00141-01	Low-Dose	+23HR POST INFUSION
SA127264	FLHP-00180-01	Low-Dose	+23HR POST INFUSION
SA127265	FLHP-00031-01	Low-Dose	+23HR POST INFUSION
SA127266	FLHP-00192-01	Low-Dose	+23HR POST INFUSION
SA127267	FLHP-00137-01	Low-Dose	+23HR POST INFUSION
SA127268	FLHP-00065-01	Low-Dose	+23HR POST INFUSION
SA127269	FLHP-00134-01	Low-Dose	+23HR POST INFUSION
SA127270	FLHP-00123-01	Low-Dose	+23HR POST INFUSION
SA127271	FLHP-00124-01	Low-Dose	+47HR POST INFUSION
SA127272	FLHP-00191-01	Low-Dose	+47HR POST INFUSION
SA127273	FLHP-00179-01	Low-Dose	+47HR POST INFUSION
SA127274	FLHP-00120-01	Low-Dose	+47HR POST INFUSION
SA127275	FLHP-00144-01	Low-Dose	+47HR POST INFUSION
SA127276	FLHP-00154-01	Low-Dose	+47HR POST INFUSION
SA127277	FLHP-00135-01	Low-Dose	+47HR POST INFUSION
SA127278	FLHP-00099-01	Low-Dose	+47HR POST INFUSION
SA127279	FLHP-00076-01	Low-Dose	+47HR POST INFUSION
SA127280	FLHP-00033-01	Low-Dose	+47HR POST INFUSION
SA127281	FLHP-00067-01	Low-Dose	+47HR POST INFUSION
SA127282	FLHP-00155-01	Low-Dose	+4HR POST INFUSION
SA127283	FLHP-00102-01	Low-Dose	+4HR POST INFUSION
SA127284	FLHP-00064-01	Low-Dose	+4HR POST INFUSION

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Collection:

Collection ID:	CO001584
Collection Summary:	Samples were homogenized and subjected to methanol extraction then split into aliquots for analysis
Sample Type:	Blood (plasma)

Treatment:

Treatment ID:	TR001604
Treatment Summary:	Study subjects were admitted to the Clinical Research Unit (CRU) at the Translational Research Institute (TRI) at AdventHealth for 5 overnight stays. The first 2 overnight stays were used as baseline. On the 2nd day (Day -1), a baseline blood draw (-24 hours) was performed. On Day 1, a blood draw was again taken approximately 30 minutes prior to the start of the glucagon infusion. The study subjects began a ramped infusion (first 4 hours) of either saline (Placebo), Low Dose Glucagon (12.5ng/kg/min) or High Dose Glucagon (25ng/kg/min) for the next 72 hours (Inpatient). The Glucagon (GlucaGen, Novo Nordisk, Bagsværd Denmark) was administered under an FDA-approved IND (#136634). Intravenous (IV) bags of the study medication were hung together on an IV pole and changed out every 24 hours to provide a continuous infusion. With the exception of the 4-hour time point, all draws were performed in the overnight fasted state.

Treatment ID:

TR001604

Treatment Summary:

Study subjects were admitted to the Clinical Research Unit (CRU) at the Translational Research Institute (TRI) at AdventHealth for 5 overnight stays. The first 2 overnight stays were used as baseline. On the 2nd day (Day -1), a baseline blood draw (-24 hours) was performed. On Day 1, a blood draw was again taken approximately 30 minutes prior to the start of the glucagon infusion. The study subjects began a ramped infusion (first 4 hours) of either saline (Placebo), Low Dose Glucagon (12.5ng/kg/min) or High Dose Glucagon (25ng/kg/min) for the next 72 hours (Inpatient). The Glucagon (GlucaGen, Novo Nordisk, Bagsværd Denmark) was administered under an FDA-approved IND (#136634). Intravenous (IV) bags of the study medication were hung together on an IV pole and changed out every 24 hours to provide a continuous infusion. With the exception of the 4-hour time point, all draws were performed in the overnight fasted state.

Sample Preparation:

Sampleprep ID:	SP001597
Sampleprep Summary:	Briefly, samples were homogenized and subjected to methanol extraction then split into aliquots for analysis by ultrahigh performance liquid chromatography/mass spectrometry (UHPLC/MS) in the positive (two methods) and negative (two methods) mode. Metabolites were then identified by automated comparison of ion features to a reference library of chemical standards followed by visual inspection for quality control.

Sampleprep ID:

SP001597

Sampleprep Summary:

Briefly, samples were homogenized and subjected to methanol extraction then split into aliquots for analysis by ultrahigh performance liquid chromatography/mass spectrometry (UHPLC/MS) in the positive (two methods) and negative (two methods) mode. Metabolites were then identified by automated comparison of ion features to a reference library of chemical standards followed by visual inspection for quality control.

Chromatography:

Chromatography ID:	CH001835
Instrument Name:	Waters Acquity
Column Name:	Waters Acquity BEH C18 (100 x 2mm,1.7um)
Chromatography Type:	Reversed phase

Chromatography ID:	CH001836
Instrument Name:	Waters Acquity
Column Name:	Waters Acquity BEH C18 (100 x 2mm,1.7um)
Chromatography Type:	Reversed phase

Chromatography ID:	CH001837
Instrument Name:	Waters Acquity
Column Name:	Waters Acquity BEH C18 (100 x 2mm,1.7um)
Chromatography Type:	Reversed phase

Chromatography ID:	CH001838
Instrument Name:	Waters Acquity
Column Name:	Waters Acquity BEH Amide (150 x 2.1mm,1.7um)
Chromatography Type:	HILIC

Analysis:

Analysis ID:	AN002511
Analysis Type:	MS
Chromatography ID:	CH001835
Num Factors:	18
Num Metabolites:	177
Rt Units:	Seconds
Units:	scaled units

Analysis ID:	AN002512
Analysis Type:	MS
Chromatography ID:	CH001836
Num Factors:	18
Num Metabolites:	66
Rt Units:	Seconds
Units:	scaled units

Analysis ID:	AN002513
Analysis Type:	MS
Chromatography ID:	CH001837
Num Factors:	18
Num Metabolites:	297
Rt Units:	Seconds
Units:	scaled units

Analysis ID:	AN002514
Analysis Type:	MS
Chromatography ID:	CH001838
Num Factors:	18
Num Metabolites:	109
Rt Units:	Seconds
Units:	scaled units