Characterization of Metabolic and Brain Effects of Rising... | NCT03061227

Studies
Characterization of Metabolic and Brain Effects of Rising Glucagon During an Oral Glucose Challenge

NCT03061227

Sponsor

University Hospital Tuebingen

Status

Completed

Last Update Posted

May 5, 2020Actual

Enrollment

32Actual

Phase

Not Applicable

Conditions

Metabolic Syndrome
Diabetes

Interventions

Intravenous glucagon
Intravenous saline

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 10, 2017Actual

Primary Completion Date

Jan 17, 2019Actual

Completion Date

Apr 30, 2020Actual

First Submitted Date

Feb 9, 2017

First Submission Date that Met QC Criteria

Feb 17, 2017

First Posted Date

Feb 23, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2020

Last Update Posted Date

May 5, 2020Actual

Description Module

Brief Summary

The investigators previously characterized a phenotype with non-suppressed glucagon at 120 minutes after standardized oral glucose load. This phenotype is associated with healthy metabolic traits such as lower BMI, higher insulin sensitivity and lower liver fat content. Glucagon is a pleiotropic hormone that, besides its main action on increasing endogenous glucose production, also reduces appetite and increases basal energy expenditure. The aims of this study are to i. detect functional differences in the appetite-related central nervous system (CNS) areas between the suppressed and non-suppressed glucagon phenotype ii. mimick the non-suppressed glucagon phenotype in those participants who suppress glucagon by administering a very-low-dose glucagon infusion and retest them.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intravenous glucagon	Active Comparator	Low-dose glucagon infusion (0.5 pmol/min/kg body weight) over 150 minutes during a standardized 75 g oral glucose tolerance test	Drug: Intravenous glucagon
Intravenous saline	Placebo Comparator	Saline infusion over 150 minutes during a standardized 75 g oral glucose tolerance test	Drug: Intravenous saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intravenous glucagon	Drug	Randomized application of glucagon or saline during oral glucose tolerance test	Intravenous glucagon

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Brain activity	Resting-state brain activity assessed by fMRI	change from baseline to 120 minutes after oral glucose challenge

Secondary Outcomes

Measure	Description	Time Frame
Hunger rating	On visual analogue scale	before and 150 minutes after oral glucose challenge and start of glucagon/saline infusion
Brain response to food cues	Assessed by functional magnetic resonance imaging (fMRI)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI 18.5- 29.9 kg/m2
written informed consent

Exclusion Criteria:

Current
1. febrile infection with temperatures> 38.5 ° C in the last 14 days
2. Blood donation within the last 12 weeks Pre-study Inclusion
Chronic diseases:
1. Diabetes mellitus
2. Known liver diseases (hepatitisB/C, hemochromatosis, NASH)
3. Chronic inflammatory diseases (rheumatoid arthritis, Crohn's disease, ulcerative colitis) chronic renal insufficiency
4. Cancer (known malignant disease)
5. psychiatric diagnoses (bipolar disorder, schizophrenia, psychoses, depression, agoraphobia)
6. Persons with non-removable metal parts, e.g:
  - pacemaker
  - artificial heart valves
  - metal prostheses
  - implanted magnetic metal parts (screws, plates of operations)
  - spiral
  - metal slivers / garnet splinters
  - fixed braces
  - Acupuncture needle
  - Insulin pump
  - totally implantable venous access device (port)
  - tattoos, metallic eye shadows
7. Persons with impaired sensitivity and / or increased sensitivity to heating of the body
8. Medical history of venous thromboembolism
9. alcohol consumption of more than 50g / day
10. In physical examination:
  
  blood pressure > 160/100 mmHg pathologic cardiac murmurs (diastolic or systolic louder than 2/6)
11. in the blood test: fasting glucose ≥ 125 mg/dl or HbA1c ≥ 6.5% AST or ALT> 2.5x upper limit of the reference range (> 125 U/l) Hb <12 g/dl C reactive protein (CRP) > 5 mg / dL or leukocytes> 15000/μl

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D024821	Metabolic Syndrome
D003920	Diabetes Mellitus

ID	Term
D007333	Insulin Resistance
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases