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

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.

Combined analysis:

Analysis ID	AN002511	AN002512	AN002513	AN002514
Analysis type	MS	MS	MS	MS
Chromatography type	Reversed phase	Reversed phase	Reversed phase	HILIC
Chromatography system	Waters Acquity	Waters Acquity	Waters Acquity	Waters Acquity
Column	Waters Acquity BEH C18 (100 x 2mm,1.7um)	Waters Acquity BEH C18 (100 x 2mm,1.7um)	Waters Acquity BEH C18 (100 x 2mm,1.7um)	Waters Acquity BEH Amide (150 x 2.1mm,1.7um)
MS Type	ESI	ESI	ESI	ESI
MS instrument type	Orbitrap	Orbitrap	Orbitrap	Orbitrap
MS instrument name	Thermo Q Exactive Orbitrap	Thermo Q Exactive Orbitrap	Thermo Q Exactive Orbitrap	Thermo Q Exactive Orbitrap
Ion Mode	POSITIVE	POSITIVE	NEGATIVE	NEGATIVE
Units	scaled units	scaled units	scaled units	scaled units

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

MS:

MS ID:	MS002329
Analysis ID:	AN002511
Instrument Name:	Thermo Q Exactive Orbitrap
Instrument Type:	Orbitrap
MS Type:	ESI
MS Comments:	Proprietary analytical software for integration and peak picking
Ion Mode:	POSITIVE

MS ID:	MS002330
Analysis ID:	AN002512
Instrument Name:	Thermo Q Exactive Orbitrap
Instrument Type:	Orbitrap
MS Type:	ESI
MS Comments:	Proprietary analytical software for integration and peak picking
Ion Mode:	POSITIVE

MS ID:	MS002331
Analysis ID:	AN002513
Instrument Name:	Thermo Q Exactive Orbitrap
Instrument Type:	Orbitrap
MS Type:	ESI
MS Comments:	Proprietary analytical software for integration and peak picking
Ion Mode:	NEGATIVE

MS ID:	MS002332
Analysis ID:	AN002514
Instrument Name:	Thermo Q Exactive Orbitrap
Instrument Type:	Orbitrap
MS Type:	ESI
MS Comments:	Proprietary analytical software for integration and peak picking
Ion Mode:	NEGATIVE