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OpenTrials
Completed

NCT Number: NCT04510155

Liver Glycogen Dynamics

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

Completed

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Key information

Conditions

Hepatic Glycogen

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University

Maastricht, Limburg, 6229ER, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Overnight fasting duration

Behavioral

Subjects will adhere to overnight fasting protocol for 1 day

Primary outcomes

  1. Hepatic glycogen content

    Time frame: 1 hour

    Measured with 13C-MRS

Secondary outcomes

  1. Substrate oxidation

    Time frame: 14 hours

    Measured as RQ

Other outcomes

  1. Intrahepatic fat content and composition (1H-MRS)

    Time frame: 30 minutes

    Measured with 1H-MRS

  2. De novo lipogenesis (DNL)

    Time frame: 20 hours

    measured as percentage of palmitate in VLDL-TG originating from DNL

  3. Hepatic fat oxidation

    Time frame: 5 hours

    measured as plasma BHB levels

  4. Liver volume

    Time frame: 5 minutes

    Measured with MRI

  5. Substrate oxidation

    Time frame: 30 minutes

    measured with indirect calorimetry

  6. Plasma metabolites related to energy metabolism

    Time frame: 5 hours

    measured in plasma samples

  7. Body composition

    Time frame: 5 minutes

    fat mass/fat free mass measured with BodPod

Sponsors and collaborators

Lead sponsor

Maastricht University

Other

Registry information

Official study title

Liver Glycogen Dynamics and Substrate Oxidation in Lean Healthy Volunteers

Acronym: LGD

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 12, 2020
Registry last updated
Jun 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.