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Evaluating Metabolic Health in Individuals With Extreme Obesity

26. mai 2026 oppdatert av: Christian Rodriguez, Pennington Biomedical Research Center

Evaluating Energy Metabolism and Metabolic Health in Individuals With Extreme Obesity

This research will evaluate energy metabolism (expenditure and fat oxidation), metabolic flexibility (response to a high-fat test meal) in 10 individuals with a BMI ≥60 kgm2 using gold-standard assessments of energy metabolism, metabolic flexibility, and body composition. Males and females (18-80 y) with extreme obesity (BMI: ≥60 kg/m2) will be recruited from Baton Rouge, Louisiana. Exclusion criteria include major organ failure, uncontrolled endocrine disease, severe psychiatric illness, pregnancy, and inability to comply with study procedures. The total duration of participation for each individual is estimated at approximately 10 days. If qualified, participants (BMI≥60 kg/m2; n=10) will complete one outpatient visit and one inpatient visit with 36hr metabolic chamber testing.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

For visit 1, Subjects will arrive at the outpatient clinic following an overnight fast (nothing to eat or drink, except water, for 10 hours) and the following tests will be performed: anthropometry, blood pressure, pulse rate, temperature, pregnancy test for women, collection of fasting and timed urine samples, fasting and timed blood draws, isotope dilution for sodium bromide, dual-energy X-ray absorptiometry, bioelectrical impedance analysis, ultrasound, accelerometer distribution, and completion of multiple questionnaires. Then, participants will wear the accelerometer and complete an ASA24 questionnaire from Visit 1 to Visit 2-D1, in which participants will return for the first metabolic chamber stay. For D3-Creatine assessment, participants will be instructed to collect an additional urine sample within 5-6 days of Visit 1 that will be dropped off when they arrive for their V2-D1 visit at Pennington Biomedical.

For Visit 2-D1, seven days after being dosed with DLW, subjects will arrive at the inpatient clinic following an overnight fast (nothing to eat or drink, except water, for at least 10 hours). The purpose of this visit is to collect urine samples for D3, DLW, remove the accelerometer, and complete the first overnight metabolic chamber visit, employing a high-fat test meal to assess metabolic flexibility. During this visit, the following tests will be performed: anthropometry, blood pressure, pulse rate, temperature, fasting urine sample, fasting blood draw, accelerometer removal, standardized breakfast and lunch, 13-h overnight stay in the metabolic chamber with a high-fat dinner, urine collection throughout the chamber stay, and VAS before and after lunch and dinner.

Lastly, for Visit 2-D2, upon completing the first overnight inpatient stay in the metabolic chamber (previous 13 hours), participants will exit the chamber at 0700 for one hour to allow for re-calibration of the chambers. Participants will be fasted since their high-fat dinner meal the previous night (approximately 11.5 hours) and will have their metabolic weight taken along with a fasting blood draw. They will then re-enter the metabolic chamber at 0800 and begin a 23-h chamber stay consisting of controlled meals throughout the stay. The purpose of this visit is to collect 23-h chamber data pertaining to various metrics of energy expenditure (e.g., BMR, RMR, TEF, SMR, etc.) and substrate oxidation (i.e., respiratory quotient). During this visit, the following tests will be performed: anthropometry, blood pressure, pulse rate, temperature, fasting blood draw, 23-h stay in the metabolic chamber with controlled meals, urine collection throughout the chamber stay, and VAS before and after lunch and dinner.

After completing of the second overnight chamber stay (Visit 2-D2), participants will exit the metabolic chamber and have their metabolic weight taken.

Studietype

Observasjonsmessig

Registrering (Antatt)

10

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

The population for this study is individuals aged 18 to 80 years old who have a BMI greater than or equal to 60 kg/m2 who are willing to consume pre-prepared meals and are willing to have biospecimens and images stored for future use. The reason for seeking to evaluate this specific population is because individuals with extreme obesity possess high surgical and comorbidity risks, but there is a very small amount of research conducted in these individuals.

Beskrivelse

Inclusion Criteria:

  • Healthy male or female
  • Between 18 - 80 years of age
  • BMI ≥60 kg/m2
  • Willing to consume pre-prepared meals
  • Willing to comply with the study procedures.
  • Willing to have biospecimens and images stored for future use.

Exclusion Criteria:

  • Diabetic individuals with complications such as:

    • Diabetic eye disease requiring laser treatment
    • Diabetic nerve disease associated with foot ulcers or amputations
    • Diabetic vascular disease associated with gangrene or amputation
    • Diabetic kidney disease accompanied by a creatinine greater than 2.0 mg/dL
    • Individuals with prior gastrointestinal surgery except appendectomy or cholecystectomy
  • Individuals with untreated thyroid disease
  • Individuals with untreated or poorly controlled binge eating disorder, bulimia, substance abuse or dependence, mania, and psychosis.
  • Women who are pregnant, trying to become pregnant, or currently breastfeeding.
  • Individuals with major organ system failure like cirrhosis, hepatic insufficiency, portal hypertension, severe renal insufficiency or on dialysis, severe arterial insufficiency, dementia or the inability to give an informed consent.
  • Being unwilling to comply with the study procedures.
  • Not willing to have biospecimens and/or images stored for future research use.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Metabolic Flexibility
Ten Males and females (18-80 y) with extreme obesity (BMI: ≥60 kg/m2) will complete one outpatient visit and one inpatient visit with 36 hours of metabolic chamber testing evaluate energy metabolism (expenditure and fat oxidation), metabolic flexibility (response to a high-fat test meal) using gold-standard assessments of energy metabolism, metabolic flexibility, and body composition.
Annen: High-fat test meal
At Visit 2-D1, subjects will enter the chamber at approximately 17:30 and exit the following morning at 07:00. Energy expenditure, respiratory exchange ratio (RER), and 12-h oxidation of CHO, fat, and protein will be calculated per standard PBRC protocols. While in the chamber, participants will collect all their urine for measurement of urinary nitrogen. Subjects will be served one high-fat meal while they are in the chamber (40% of the daily energy requirements).
Andre navn:
  • metabolic flexibility

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
24-hour Energy Expenditure
Tidsramme: Day 9
24-hour energy expenditure will be assessed from participants spending 23 hours in a metabolic chamber.
Day 9
24-hour Fat Oxidation
Tidsramme: Day 9
This will be collected from the 23-hour chamber stay during Visit 2, Day 2. Specifically, this represents the total grams of fat oxidized over the 23-hour stay, calculated from indirect calorimetry stoichiometry.
Day 9
Basal Energy Expenditure
Tidsramme: Day 9
This represents the amount of energy expended under strict basal conditions: post-absorptive (typically 10-12h fasted), thermoneutral, fully awake but supine and motionless, no recent physical activity. This will be collected from the 23-hour metabolic chamber stay.
Day 9
Resting Energy Expenditure
Tidsramme: Day 9
This is the energy expended at rest but under less stringent conditions than basal: seated or supine, awake, post-absorptive but with less rigor about prior activity, temperature, and emotional state. This will be collected from the 23-hour metabolic chamber stay.
Day 9
Sleeping Metabolic Rate
Tidsramme: Day 9
This is the energy expenditure during sleep, typically computed from the lowest stable ~3-hour window between roughly 02:00 and 05:00 when arousal and movement are minimal. Per our Standard Operating Procedures, this will be computed between 01:00 and 05:00.
Day 9
Thermic Effect of Food
Tidsramme: Day 9
This represents the postprandial rise in energy expenditure above the pre-meal baseline, integrated over the period until energy expenditure returns to baseline (typically 4-6 hours for a mixed meal). This reflects the energy cost of digestion, absorption, and substrate processing, plus a sympathetic activation component.
Day 9
Spontaneous Physical Activity
Tidsramme: Day 9
This is the energy expended on non-volitional movement: fidgeting, postural adjustments, small spontaneous movements during otherwise sedentary periods in the chamber. It is commonly measured by radar/Doppler motion sensors and quantified either as a fraction of chamber time active (% activity) or as the energy cost of activity above sleeping metabolic rate.
Day 9
Free-living Total Daily Energy Expenditure
Tidsramme: Day 1 to Day 8
This is the gold-standard free-living EE measurement: participants drink a dose of ²H₂¹⁸O, and the differential elimination rates of the two isotopes over ~7-14 days yield CO₂ production and therefore EE under habitual living conditions. It captures everything the chamber misses: occupational and recreational activity, environmental temperature variation, real meal patterns.
Day 1 to Day 8

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time to Food Quotient
Tidsramme: Day 8
This is the amount of minutes from meal ingestion until RER first reaches (or crosses) the meal's FQ. This represents the speed of the switch of fuel oxidation rather than its endpoint. A flexible system gets there quickly; an inflexible one takes hours or never arrives.
Day 8
Respiratory Exchange Ratio: Food Quotient Ratio
Tidsramme: Day 8
This is the measured respiratory exchange ratio divided by the meal's food quotient (the theoretical RER if the meal were fully oxidized as ingested). A ratio of 1.0 means whole-body substrate oxidation has fully matched the macronutrient composition of what was just eaten; <1.0 means oxidation is lagging behind intake (fat-dominant fuel selection persisting after a mixed or high-carb meal); >1.0 means net lipogenesis or carryover carb oxidation. The FQ of the high-fat test meal will be used.
Day 8
ΔRespiratory Exchange Ratio Nadir
Tidsramme: Day 8
This represents the drop from a reference RER (typically pre-meal fasting baseline, sometimes overnight minimum) to the lowest RER value observed. In a high-fat meal challenge this captures the magnitude of the fat-oxidation excursion: how far down the RER pushes when the meal is fat-dominant.
Day 8
Post-meal Respiratory Exchange Ratio Slope
Tidsramme: Day 8
This represents the rate of RER change in the early postprandial window, usually fit as a linear slope over the first 30-90 minutes after ingestion. A steep slope would mean a rapid switch (metabolically flexible) and a shallow slope would indicate impaired metabolic flexibility.
Day 8
Time to Respiratory Exchange Ratio Nadir
Tidsramme: Day 8
This represents the amount of minutes from high-fat meal meal ingestion until RER reaches its lowest value. Pairing this will the change in RER nadir helps describe the fat oxidation excursion. That is, nadir magnitude expresses how much fat oxidation increased, whereas time-to-nadir exhibits how long it took to get there.
Day 8

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Skeletal Muscle Mass
Tidsramme: Day 1 to Day 5
Skeletal muscle mass will be measured using D3-creatine dilution. Participants will be administered a 60 mg capsule with D3-creatine during Visit 1. Spot urine specimens will be collected between 120 hours (5 days) and 144 hours (6 days) after administration of the D3-creatine dose.
Day 1 to Day 5
Fat-free Mass
Tidsramme: Day 1
Fat-free mass will be quantified by dual-energy X-ray absorptiometry and two bioelectrical impedance analysis devices (InBody S10 and ImpediMed SFB7) during visit 1.
Day 1
Fat Mass
Tidsramme: Day 1
Fat mass will be estimated by dual-energy X-ray absorptiometry and two bioelectrical impedance analysis devices (InBody S10 and ImpediMed SFB7) during visit 1.
Day 1
Body Fat Percentage
Tidsramme: Day 1
Body fat percentage will be estimated by dual-energy X-ray absorptiometry and two bioelectrical impedance analysis devices (InBody S10 and ImpediMed SFB7) during visit 1.
Day 1
Extracellular Water
Tidsramme: Day 1
At Visit 1, a blood sample of 3 ml will be collected before ingesting an appropriate amount of sodium bromide based on body weight diluted in deionized water. A blood sample of 3 ml will be collected 4 hours after ingestion. During the 4-hour period participants must refrain from eating anything, but they can drink water if needed.
Day 1
Total Body Water
Tidsramme: Day 1
Total body water will be determined via two bioelectrical impedance devices (InBody S10 and ImpediMed SFB7) and deuterium dilution.
Day 1

Samarbeidspartnere og etterforskere

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Sponsor

Pennington Biomedical Research Center

Etterforskere

  • Hovedetterforsker: Christian Rodriguez, PhD, Pennington Biomedical Research Center

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juli 2026

Primær fullføring (Antatt)

1. juli 2026

Studiet fullført (Antatt)

1. august 2026

Datoer for studieregistrering

Først innsendt

13. mai 2026

Først innsendt som oppfylte QC-kriteriene

26. mai 2026

Først lagt ut (Faktiske)

29. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • PBRC 2026-011

Plan for individuelle deltakerdata (IPD)

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Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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