Liver Glycogen Dynamics

Hepatic Glycogen Clinical Trial

— LGD  

Official title:

Liver Glycogen Dynamics and Substrate Oxidation in Lean Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04510155
• Other study ID #: NL72118.068.20
• Status: Completed
• Phase: N/A
• Start date: September 11, 2020
• Est. completion date: May 21, 2021

Study information

• Verified date: May 2021
• Source: Maastricht University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effect of prolonged overnight fasting in the hepatic glycogen stores

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 21, 2021
• Est. primary completion date: May 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

• Participants are able to provide signed and dated written informed consent prior to any study specific procedures

• Caucasian (people will be excluded when having a =50% racial African/Asian background)

• Participants should have suitable veins for cannulation or repeated venipuncture

• Women are post-menopausal (defined as at least 1 year post cessation of menses)

• Men and women aged = 45 and = 75 years at the start of the study

• Body mass index (BMI) 18.5 - 25 kg/m2

• Stable dietary habits (no weight loss or gain >3kg in the past 3 months)

• Sedentary lifestyle (not more than 3 hours of vigorous sports per week)

Exclusion Criteria:

• Type 2 Diabetes Mellitus

• Active diseases (cardiovascular, diabetes, liver, kidney, cancer or other)

• Any contraindication for MRI scanning

• Alcohol consumption of >2 servings per day

• Regular smoking

• No use of medication interfering with investigated study parameters (as determined by responsible physician)

• Participants who do not want to be informed about unexpected medical findings, or do not wish that their physician

Related Conditions & MeSH terms

• Hepatic Glycogen

Intervention

Behavioral:
• Overnight fasting duration
Subjects will adhere to overnight fasting protocol for 1 day

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intrahepatic fat content and composition (1H-MRS)	Measured with 1H-MRS	30 minutes
Other	De novo lipogenesis (DNL)	measured as percentage of palmitate in VLDL-TG originating from DNL	20 hours
Other	Hepatic fat oxidation	measured as plasma BHB levels	5 hours
Other	Liver volume	Measured with MRI	5 minutes
Other	Substrate oxidation	measured with indirect calorimetry	30 minutes
Other	Plasma metabolites related to energy metabolism	measured in plasma samples	5 hours
Other	Body composition	fat mass/fat free mass measured with BodPod	5 minutes
Primary	Hepatic glycogen content	Measured with 13C-MRS	1 hour
Secondary	Substrate oxidation	Measured as RQ	14 hours