Impact of Metabolic Flexibility on Changes in Metabolic Health

NCT06340321 | Completed

• 1 other identifier: PBRC 2023-081
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Metabolic flexibility is the capacity to adapt fuel oxidation to fuel availability so that ATP synthesis can match its cellular demands. Thus, for example, increases in glucose availability after a meal would increase glucose oxidation, while increases in lipid availability during fasting would increase lipid oxidation. Enhanced metabolic flexibility has been proposed to protect humans from metabolic diseases. Nevertheless, most studies examining associations between metabolic flexibility and metabolic health outcomes have used cross-sectional designs. Whether impaired metabolic flexibility causes or results from metabolic health impairment is thus unclear. In this study, the investigators will use the data from a study conducted approximately 16 years ago in healthy participants without obesity. Using the data already collected in that study, the metabolic flexibility of each participant will be calculated. To test the association between metabolic flexibility and the change in metabolic health, the investigators will call back all the participants for a single follow-up visit to reassess several metabolic health outcomes. Thus, the main aim of the study is to test the association between metabolic flexibility and the change in metabolic health outcomes after 16 years in humans.

Conditions

Obesity; Metabolic Syndrome

Outcome Measures

Primary Outcomes (10)

• Glucose

  Circulating concentration of glucose in mg/dL

  At baseline (in 2008-2009) and after approximately 16 years (2024-2025)

• Total cholesterol

  Circulating concentration of cholesterol in mg/dL

  At baseline (in 2008-2009) and after approximately 16 years (2024-2025)

• HDL cholesterol

  Circulating concentration of HDL cholesterol in mg/dL

  At baseline (in 2008-2009) and after approximately 16 years (2024-2025)

• LDL cholesterol

  Circulating concentration of LDL cholesterol in mg/dL

  At baseline (in 2008-2009) and after approximately 16 years (2024-2025)

• Triglycerides

  Circulating concentration of triglycerides in mg/dL

  At baseline (in 2008-2009) and after approximately 16 years (2024-2025)

• HOMA-IR

  Homeostatic Model of Assessment of Insulin Resistance computed from the circulating concentrations of glucose and insulin

  At baseline (in 2008-2009) and after approximately 16 years (2024-2025)

• Blood pressure

  Including systolic, diastolic, and mean blood pressure in mmHg

  At baseline (in 2008-2009) and after approximately 16 years (2024-2025)

• Waist circumference

  Measured in cm

  At baseline (in 2008-2009) and after approximately 16 years (2024-2025)

• Body mass index

  Calculated from the ratio between the weight and height, and expressed in kg/m2

  At baseline (in 2008-2009) and after approximately 16 years (2024-2025)

• Body fat percentage

  Measured by DXA and expressed as percentage of body weight

  At baseline (in 2008-2009) and after approximately 16 years (2024-2025)

Study Arms (1)

Insight study cohort

The proposed study will include the individuals who participated in the baseline assessment of the InSight study at Pennington Biomedical in 2008-2009. These participants were not subjected to any intervention.

Diagnostic Test: Metabolic flexibility in the fasted state; Other: Metabolic flexibility in euglycemic-hyperinsulinemic clamp; Other: Metabolic flexibility in the metabolic chamber

Interventions

Metabolic flexibility in the fasted state DIAGNOSTIC_TEST

Measured at baseline during the InSight study (2008-2009). Calculated as the respiratory exchange ratio in the fasting state adjusted for the circulating concentrations of free fatty acids

Insight study cohort

Metabolic flexibility in euglycemic-hyperinsulinemic clamp OTHER

Measured at baseline during the InSight study (2008-2009). Calculated as the change in respiratory exchange ratio adjusted for glucose disposal rate

Insight study cohort

Metabolic flexibility in the metabolic chamber OTHER

Measured at baseline during the InSight study (2008-2009). Calculated as the difference between awake respiratory exchange ratio (from 8 a.m. to 11 p.m.) and sleeping respiratory exchange ratio during a 23-hour stay in the metabolic chamber

Insight study cohort

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals who participated in the InSight study at Pennington Biomedical in 2008-2009. Such study enrolled healthy men and women aged 20-36 years, with a body mass index \<27.5 kg/m2, and a fasting glycemia \<126 mg/dL.

You may qualify if:

• Individuals who participated in the InSight study at Pennington Biomedical in 2008-2009.

You may not qualify if:

• Women who are currently pregnant or breastfeeding, have been pregnant in the last 12 months, and/or were breastfeeding in the last 6 months.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Obesity; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Rodrigo Fernández-Verdejo, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

• Eric Ravussin, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

• Leanne Redman, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Visiting Assistant Professor

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 1, 2024
• Study Start: October 9, 2024
• Primary Completion: August 25, 2025
• Study Completion: August 27, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After publication of the results for the main outcome
• Access Criteria: Upon appropriate request

Locations

US (1)