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How the Body Processes Sugar After Eating, in People With Different Body Weights

1 de julho de 2026 atualizado por: Marlou Dirks, Wageningen University

The Metabolic Effects of a Hyperglycaemic Meal in Lean and Obese Individuals Using a [14C]-Glucose Microtracer Approach

The goal of this clinical trial is to learn how a high-glycaemic meal affects the way the body processes glucose in healthy adults who are either lean or have obesity. The main questions it aims to answer are: Is the polyol pathway (conversion of glucose into sorbitol and fructose) more active after a hyperglycaemic meal? Is this pathway more active in individuals with obesity compared with lean individuals? We will compare people who eat a high-glycaemic meal with those who eat a low-glycaemic meal to see whether meal type changes how glucose is metabolized in the body. Participants will drink a small amount of 14C-labelled glucose so researchers can trace how the body uses glucose, spend one long study day (about 12 hours in the lab) plus short morning visits on days 2 to 4, and undergo repeated measurements, including blood sampling, breath sampling, indirect calorimetry, and complete urine and stool collection for 72 hours. This information will help us understand how glucose is processed in the body and whether people with obesity handle glucose differently than lean individuals.

Visão geral do estudo

Descrição detalhada

Obesity is associated with substantial metabolic dysregulation, including impaired glucose handling, increased oxidative stress, and altered nutrient partitioning. A metabolic pathway of particular interest in this context is the polyol pathway, in which glucose is converted to sorbitol by aldose reductase and subsequently to fructose. Preclinical studies suggest that flux through this pathway increases when intracellular glucose concentrations rise, such as during hyperglycaemia or insulin resistance. Greater activity of this pathway has been linked to the formation of advanced glycation end products, oxidative stress, and stimulation of de novo lipogenesis. These mechanisms have been proposed as contributors to metabolic complications commonly observed in individuals with obesity. Despite these findings from animal and in vitro studies, polyol pathway activity and its regulation by dietary glycaemic load have not been systematically quantified in humans. This clinical trial addresses this gap by applying a highly sensitive [14C]-glucose microtracer approach to measure the metabolic fate of glucose following ingestion of meals with differing glycaemic properties in lean individuals and individuals with obesity.

The study makes use of uniformly labelled [14C]-glucose, which allows tracing of glucose-derived carbon into metabolic intermediates, expired CO₂, urine, faeces, and lipids using Accelerator Mass Spectrometry. This technology enables quantification of metabolic products with extremely small isotope doses, resulting in radiation exposure far below natural background levels. Through this approach, the study can directly assess the extent to which ingested glucose is oxidized, converted into polyol pathway intermediates, incorporated into lipids, or excreted. The microtracer method provides a level of mechanistic resolution that cannot be achieved with stable isotopes or traditional metabolic tests.

The study design includes a single 72-hour metabolic test period during which participants consume either a high- or low-glycaemic breakfast depending on group allocation. The subsequent ingestion of [14C]-glucose allows tracking of postprandial metabolic routing under these two dietary conditions. Lean participants are randomized to either glycaemic condition, whereas individuals with obesity receive the high-glycaemic meal to address the study's main objective of comparing pathway activity between lean and obese phenotypes under hyperglycaemic challenge. Although the protocol includes multiple laboratory measurements, the aim of this Detailed Description is not to reproduce the procedure schedule, but to summarize the scientific characteristics of the design. In general terms, the study integrates whole-body, biochemical, and tissue-level metabolic assessments to characterize glucose metabolism in vivo.

Whole-body energy expenditure and substrate oxidation are measured repeatedly through indirect calorimetry to determine the proportion of glucose that is oxidized versus stored or redirected into other metabolic pathways. Breath samples are collected to quantify 14CO₂ production, which provides a sensitive measure of glucose oxidation and contributes to mass balance calculations. Serial blood sampling enables the measurement of plasma glucose, insulin, and the appearance of 14C-labelled metabolites, providing insight into the dynamics of glucose disposal and conversion to sorbitol, fructose, and downstream metabolites.

A distinctive feature of this study is the assessment of forearm arteriovenous metabolite balance, obtained from arterialized and deep-venous blood sampling combined with Doppler ultrasound measurement of forearm blood flow. This technique allows calculation of tissue-specific uptake and release of glucose and glucose-derived metabolites across skeletal muscle, a major site of postprandial glucose disposal. These measurements offer a physiologically meaningful index of muscle insulin sensitivity and provide additional perspective on how glycaemic load and obesity influence metabolic flux at the tissue level.

Collection of urine and faeces for 72 hours enables full recovery of the administered tracer, allowing detailed mass balance calculations. This information reveals how much of the ingested glucose is oxidized, excreted, or directed into biosynthetic pathways. By integrating data from breath, blood, urine, and faeces, the study can comprehensively map the metabolic fate of glucose and determine how this differs across physiological states.

The primary scientific questions addressed by this study are whether polyol pathway activity increases under hyperglycaemic conditions in humans and whether individuals with obesity demonstrate greater pathway activation than lean individuals. The study further explores the relationship between polyol pathway activation and de novo lipogenesis and evaluates whether the glycaemic load of a meal modulates these pathways. By combining microtracer-based flux analysis with whole-body and tissue-specific measurements, the study aims to provide mechanistic insight into early metabolic disturbances associated with obesity.

Overall, this trial will generate foundational human data on endogenous fructose production and glucose routing in response to dietary glycaemic load. These findings may contribute to improved understanding of how carbohydrate metabolism becomes dysregulated in obesity and may support the development of nutritional or therapeutic strategies targeting glucose-handling pathways. The study also demonstrates the potential of Accelerator Mass Spectrometry as a powerful tool for investigating nutrient metabolism in vivo with minimal participant burden and extremely low radiation exposure.

Tipo de estudo

Intervencional

Inscrição (Estimado)

24

Estágio

  • Não aplicável

Contactos e Locais

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Contato de estudo

Estude backup de contato

Locais de estudo

      • Wageningen, Holanda, 6708 WD
        • Recrutamento
        • Wageningen University and Research
        • Contato:
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

Inclusion Criteria:

  • Healthy males and females using contraception during and for 3 months after the study.
  • Aged from 18-65 years at the time of signing informed consent
  • 18.5 < BMI < 25 kg·m2 or 30< BMI <35 kg·m2
  • Must be willing and able to communicate and participate in the whole study, including consumption of 14C-glucose and meals offered during study conduct
  • Must have regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day)
  • Must usually eat 3 meals per day (i.e. breakfast, lunch and dinner)

Exclusion Criteria:

  • Diabetes (Type 1, Type 2, or genetic form of diabetes)
  • Any diagnosed cardiovascular (heart) disease or high blood pressure (≥140 mmHg systolic and/or ≥90 mmHg diastolic)
  • HbA1c higher than 53 mmol/mol
  • History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastro-intestinal disease, immunodeficiency, endocrine, neurological, or psychiatric disorders
  • Any diagnosed respiratory disease, such as COPD or asthma
  • Any previous motor disorders or disorders in muscle and/or lipid metabolism
  • Known severe kidney problems
  • Presence of an ulcer in the stomach or gut and/or strong history of indigestion
  • Recent or chronic history of diarrhoea
  • Known anaemia
  • A personal or family history of thrombosis (clots), epilepsy, seizures, or schizophrenia.
  • Regular use of dietary supplements (>3 times per week)
  • Chronic use of any prescribed or over the counter pharmaceuticals (excluding oral contraceptives and contraceptive devices)
  • History of any drug or alcohol abuse in the past two years
  • A confirmed positive alcohol breath test at screening or admission
  • Drug use
  • Claustrophobia
  • Subjects who are on a weight loss diet or following a high calorific/high protein diet to gain weight
  • Subjects with functional constipation
  • Any known food allergies or intolerances to the 14 major food allergens (celery, cereals containing gluten, crustaceans, eggs, fish, lupin, milk, molluscs, mustard, tree nuts, peanuts, sesame seeds, soybeans, sulphur dioxide and sulphites) or history of a malabsorption syndrome including coeliac disease
  • Subjects who have regular gastrointestinal complaints including abdominal pain, stomach upsets and borborygmi or known or suspected irritable bowel syndrome
  • Currently taking part in another scientific research
  • Having received a product with 14C in the past 12 months
  • Pregnant or breastfeeding
  • Smoking or having used nicotine-containing products in the 6 months prior to the study.
  • Subjects who have taken antibiotics within the 60 days prior to the adaptation period.
  • Currently involved in a structured progressive resistance training programme (>3 times per week)
  • Sedentary lifestyle as assessed using the International Physical Activity Questionnaire [IPAQ].
  • Unable to give consent
  • Employed or undertaking a thesis or internship at the department of Human and Animal Physiology

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Ciência básica
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: A - Lean individuals (Low-glycemic breakfast)
Lean participants randomized to consume a low-glycemic breakfast prior to administration of an oral [¹⁴C]-glucose microtracer to assess postprandial glucose metabolism.
Participants receive a single oral microtracer dose of [14C] glucose (≤10 kBq / 270 nCi) mixed with 1 g unlabeled glucose, administered immediately after a low glycemic breakfast. The dose is prepared fresh on the morning of administration and consumed as a liquid drink. This approach enables tracing of glucose metabolism using Accelerator Mass Spectrometry (AMS) at extremely low radiation exposure (~0.006 mSv). The intervention is combined with indirect calorimetry, serial blood sampling (including arterialized and deep-venous lines), expired air collection for 14CO₂ recovery, and pooled urine/feces collection over 72 hours to quantify metabolic fate and pathway activity.
Experimental: B - Lean individuals (High-glycemic breakfast)
Lean participants randomized to consume a high-glycemic breakfast prior to administration of an oral [¹⁴C]-glucose microtracer to assess postprandial glucose metabolism.
Participants receive a single oral microtracer dose of [14C] glucose (≤10 kBq / 270 nCi) mixed with 1 g unlabeled glucose, administered immediately after a high glycemic breakfast. The dose is prepared fresh on the morning of administration and consumed as a liquid drink. This approach enables tracing of glucose metabolism using Accelerator Mass Spectrometry (AMS) at extremely low radiation exposure (~0.006 mSv). The intervention is combined with indirect calorimetry, serial blood sampling (including arterialized and deep-venous lines), expired air collection for 14CO₂ recovery, and pooled urine/feces collection over 72 hours to quantify metabolic fate and pathway activity.
Experimental: C - Individuals with obesity (High-glycemic breakfast)
Participants with obesity consume a high-glycemic breakfast prior to administration of an oral [¹⁴C]-glucose microtracer to assess postprandial glucose metabolism.
Participants receive a single oral microtracer dose of [14C] glucose (≤10 kBq / 270 nCi) mixed with 1 g unlabeled glucose, administered immediately after a high glycemic breakfast. The dose is prepared fresh on the morning of administration and consumed as a liquid drink. This approach enables tracing of glucose metabolism using Accelerator Mass Spectrometry (AMS) at extremely low radiation exposure (~0.006 mSv). The intervention is combined with indirect calorimetry, serial blood sampling (including arterialized and deep-venous lines), expired air collection for 14CO₂ recovery, and pooled urine/feces collection over 72 hours to quantify metabolic fate and pathway activity.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Total mass balance (cumulative recovery of 14C)
Prazo: Baseline to 72 hours post dose
Cumulative recovery of total radioactivity across all excreta (urine, faeces, and expired CO₂) expressed as percentage of the administered dose.
Baseline to 72 hours post dose

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Polyol pathway activity (fructose-to-glucose ratio)
Prazo: Baseline to 72 hours post 14C ingestion
Ratio of 14C-fructose to 14C-glucose concentrations
Baseline to 72 hours post 14C ingestion
Polyol pathway activity (sorbitol-to-glucose ratio)
Prazo: Baseline to 72 hours post 14C ingestion
Ratio of 14C-sorbitol to 14C-glucose concentrations
Baseline to 72 hours post 14C ingestion
Polyol pathway activity (AUC-based ratio)
Prazo: Baseline to 72 hours post 14C ingestion
Ratio of area under the curve (AUC) for 14C-fructose to AUC for 14C-glucose
Baseline to 72 hours post 14C ingestion
De novo lipogenesis from glucose
Prazo: Baseline to 72 hours
Incorporation of 14C label into plasma lipids as a measure of fatty acid synthesis from glucose
Baseline to 72 hours
Caloric value of glucose
Prazo: Baseline to 72 hours
Recovery of 14C label in expired CO2 and excreta, expressed as a measure of energy yield of ingested glucose
Baseline to 72 hours
Forearm arteriovenous balance of 14C-glucose and metabolites
Prazo: 0-240 minutes post dose
Arteriovenous concentration differences of 14C-glucose and metabolites across the forearm, combined with blood flow measurements
0-240 minutes post dose
14C-labelled metabolites in carbohydrate metabolism pathways
Prazo: Baseline to 72 hours post 14C ingestion
Concentrations and 14C-enrichment of glucose, fructose, and related metabolites in plasma and erythrocytes.
Baseline to 72 hours post 14C ingestion
Carbohydrate oxidation
Prazo: Baseline to 72 hours
Carbohydrate oxidation rate measured using indirect calorimetry and calculated according to standard equations under fasted and postprandial conditions following ingestion of a high- or low-glycaemic meal.
Baseline to 72 hours
Lipid oxidation
Prazo: Baseline to 72 hours
Lipid oxidation rate measured using indirect calorimetry and calculated according to standard equations under fasted and postprandial conditions following ingestion of a high- or low-glycaemic meal.
Baseline to 72 hours
Energy expenditure
Prazo: Baseline to 72 hours
Total energy expenditure measured using indirect calorimetry and calculated according to standard equations under fasted and postprandial conditions following ingestion of a high- or low-glycaemic meal.
Baseline to 72 hours

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Polyol Pathway Activity Markers
Prazo: Baseline and up to 8 hours after 14C-glucose ingestion
Plasma and erythrocyte sorbitol concentrations
Baseline and up to 8 hours after 14C-glucose ingestion
Plasma glucose
Prazo: Baseline and up to 8 hours after 14C-glucose ingestion
Plasma glucose concentration
Baseline and up to 8 hours after 14C-glucose ingestion
Insulin
Prazo: Baseline and up to 8 hours after 14C-glucose ingestion
Serum insulin concentration
Baseline and up to 8 hours after 14C-glucose ingestion
Exploratory Metabolic Phenotyping
Prazo: Baseline and up to 8 hours after 14C-glucose ingestion
Metabolomic, proteomic, and/or transcriptomic profiles in plasma and erythrocytes
Baseline and up to 8 hours after 14C-glucose ingestion
Body Weight
Prazo: Baseline (pre-intervention)
Body weight measured in kilograms
Baseline (pre-intervention)
Height
Prazo: Baseline (pre-intervention)
Height measured in meters
Baseline (pre-intervention)
Body mass index (BMI)
Prazo: Baseline (pre-intervention)
Body mass index calculated as weight in kilograms divided by height in meters squared (kg/m²)
Baseline (pre-intervention)
Blood pressure
Prazo: Baseline (pre-intervention)
Systolic and diastolic blood pressure measured in mmHg
Baseline (pre-intervention)
Glycated haemoglobin (HbA1c)
Prazo: Baseline
HbA1c concentration in blood
Baseline

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Colaboradores

TNO

Investigadores

  • Investigador principal: Marlou Dirks, PhD, Wageningen University

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

24 de fevereiro de 2026

Conclusão Primária (Estimado)

30 de julho de 2026

Conclusão do estudo (Estimado)

30 de julho de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

17 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

1 de julho de 2026

Primeira postagem (Real)

8 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

8 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

1 de julho de 2026

Última verificação

1 de abril de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Individual participant data will not be shared outside the study team.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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