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Evaluating Metabolic Health in Individuals With Extreme Obesity

26 de mayo de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Estimado)

10

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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.
Otro: 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).
Otros nombres:
  • metabolic flexibility

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
24-hour Energy Expenditure
Periodo de tiempo: Day 9
24-hour energy expenditure will be assessed from participants spending 23 hours in a metabolic chamber.
Day 9
24-hour Fat Oxidation
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Time to Food Quotient
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Skeletal Muscle Mass
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Day 1
Total body water will be determined via two bioelectrical impedance devices (InBody S10 and ImpediMed SFB7) and deuterium dilution.
Day 1

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Pennington Biomedical Research Center

Investigadores

  • Investigador principal: Christian Rodriguez, PhD, Pennington Biomedical Research Center

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de julio de 2026

Finalización primaria (Estimado)

1 de julio de 2026

Finalización del estudio (Estimado)

1 de agosto de 2026

Fechas de registro del estudio

Enviado por primera vez

13 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

26 de mayo de 2026

Publicado por primera vez (Actual)

29 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

29 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

26 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • PBRC 2026-011

Plan de datos de participantes individuales (IPD)

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INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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