SarcopeniaWesternageNCT06438900
Investigating the Link Between Advanced Glycation End Products (AGEs) and Muscle Wasting in Sarcobesity
An observational study of Sarcopenia and Obesity, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
Trial summary
The study aims to explore whether a high level of AGEs (Advanced Glycation end products) derived from the diet may mediate diet-related muscle loss in Western-type diet, influencing the onset and progression of sarcopenia, predisposing to earlier and more severe metabolic consequences, including type 2 diabetes (T2D). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Obesity
- How many people
- 195 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jun 2024to 15 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Given a type I error rate (α) of 0.05 and a power of 80%, 195 subjects will be needed to observe a significant correlation between AGE levels and sarcobesity indices of at least 0.2. Considering the low prevalence of lipodystrophy and a recruitment duration of one year, approximately 35 subjects with this condition are expected to be included. The remaining 160 subjects will have diabetes and obesity. Furthermore, considering that the duration of diabetes may influence AGE levels and sarcobesity, both subjects with long-standing diabetes (80 patients) and those with less than one year of diagnosis (80 patients) will be selected, which can be considered comparable to subjects in pre-diabetes.
Who may be able to join
- Patients of both sexes.
- Adults.
- BMI compatible with obesity and a diagnosis of type 2 diabetes under good metabolic control (HbA1c < 7.5%) within 15 years of entry into the study or diagnosis of lipodystrophy (included in the European Consortium of Lipodystrophies (ECLip) Registry (eclip-web.org))
Who cannot join
- Age under 18 years.
- Secondary obesity or genetic diseases (Prader-Willi Syndrome, Down Syndrome); metabolic and endocrine disorders (Cushing's syndrome, hypothyroidism).
- Subjects with: Inflammatory Bowel Disease (IBD), cancer.
- Confirmed or planned pregnancy during the study participation months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
SCDU Endocrinology, AOU Ospedale Maggiore della Carità
Novara, 28100
Flavia Prodam, +39 0321 660 693, flavia.prodam@med.uniupo.it
About this study
Official title: Fighting Western-diet Derived AGEs to Mitigate Muscle Wasting in Sarcobesity:Observational Study on the Relationship Between AGE Levels and Sarcobesity in an Adult Population Affected by Obesity and Type 2 Diabetes Mellitus
The study aims to explore whether a high level of AGEs (Advanced Glycation end products) derived from the diet may mediate diet-related muscle loss in Western-type diet, influencing the onset and progression of sarcopenia, predisposing to earlier and more severe metabolic consequences, including type 2 diabetes (T2D).
The primary objective of the study is to investigate how the accumulation of AGEs is correlated with muscle loss in adult patients with obesity and type 2 diabetes or lipodystrophy in order to identify possible targets to mitigate the metabolic alterations caused by the Western diet (WD). Specifically, circulating AGEs levels on the skin will be evaluated and correlated with the stage of sarcopenia in a group of patients with obesity and a T2D diagnosis. Furthermore, the relationship between disease duration and AGE levels will be assessed.
Read more
A secondary objective will be to analyze the clinical data obtained to identify metabolites and metabolic pathways responsible for the phenotype induced by the WD.
The ultimate aim of the study is therefore to verify whether high levels of AGEs are correlated with an early and/or more pronounced onset of sarcopenia, concurrently with an increase in inflammation and oxidative stress.
Read the detailed description
The study in question is of a cross-sectional observational type. The reference population is defined by patients with obesity and a diagnosis of T2D within 15 years of entry into the study or patients with concomitant type 2 diabetes and lipodystrophy syndrome. This population was chosen because they are at high risk of sarcopenia.
Lipodystrophy includes a heterogeneous spectrum of genetic and acquired diseases characterized by loss of subcutaneous adipose tissue, ectopic fat accumulation, insulin resistance, metabolic and cardiovascular diseases, premature aging, sarcopenia, muscle pain, high-grade inflammation, epigenetic dysregulation, and mitochondrial dysfunction. Therefore, patients with T2D and lipodystrophy are highly inflamed as they generally present with a more severe T2D phenotype, presumed sarcopenic, and with a high rate of endogenous AGE production. Patients with concurrent lipodystrophy and T2D will be recruited as sarcopenic and obese subjects, representing an excellent strategy for comparison with diabetic individuals without lipodystrophy.
SUBJECTS AND METHODS A total of 195 consecutive subjects will be enrolled in the study from the Endocrinology Unit of the University of Eastern Piedmont between April 2024 and April 2026, who meet the inclusion criteria.
Study duration:
The study will last for two years corresponding to the enrollment period given the cross-sectional nature of the study.
Statistical Analysis
Descriptive statistics will be used to summarize sociodemographic, anthropometric, clinical, and lifestyle-related information collected. Categorical variables will be summarized using absolute frequencies and percentages, while numerical variables will be summarized using mean and standard deviation or median and interquartile range if not normally distributed according to the Shapiro-Wilk test and after observation of Q-Q plots (quantile-quantile plot).
The Pearson correlation coefficient or the corresponding non-parametric Spearman rank correlation coefficient and confidence intervals will be initially calculated to assess the correlation between the levels of individual AGEs and skeletal muscle mass (SMM), handgrip strength (HGS), parameters of body composition, and functional parameters of skeletal muscle. Subsequently, linear regression models will be used to evaluate the relationship between AGEs and sarcopenia-defining indices adjusted for age, sex, duration of diabetes, and other potential confounding factors such as inflammation, adherence to the Western diet, and levels of physical activity. The LASSO method will be used for variable selection in multivariable regression models.
Univariable and multivariable Poisson regression models with robust variance will be used to estimate relative prevalence risks for the association between AGEs and patient characteristics with sarcopenia presence and the corresponding confidence intervals.
An integration of clinical data, biochemical data, AGE levels, and patient omic signatures will be performed to develop a multifactorial diagnostic model using multivariate statistical analysis (e.g., factor analysis, principal component analysis, cluster analysis, discriminant analysis, partial least squares analysis, logistic regression) and data-driven approaches. Machine learning algorithms will be applied to prioritize and weigh risk factors. These analyses will be conducted with internal statistical consultation already utilized by the group.
Expected Results
With this study, the investigators expect to obtain further information and correlations between nutritional assessment and its impact on inflammation, sarcopenia definition, and progression, obesity, and T2D, based on body measurements and clinical parameters. Through biochemical, hormonal, and metabolomic analyses conducted on biological samples, te investigators expect to identify possible markers related to the presence of AGEs. In conclusion, the primary expected outcome would be to identify a positive correlation between AGE accumulation in at least one compartment (skin, plasma, urine) and the severity of sarcopenia, thus obtaining a rapid and non-invasive method to identify individuals at high risk of developing muscle wasting (MW) and identify correlations between AGE levels and other metabolic characteristics, even in lipodystrophic pathology.
- Conditions
- Sarcopenia, Obesity
- Keywords
- Advanced glycation end products, Sarcobesity, Obesity, Sarcopenic
- Medical subject headings
- Sarcopenia, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal mass functionality for sarcopenia definition
Functional parameters of skeletal muscle defined by muscle strength measured through hand grip strength (HGS) The test requires the patient to tighten the handle the dynamometer with the maximum possible force, then maintaining the contraction for at least 5 seconds; you should repeat the test on the other hand (it is normal that the dominant expresses a higher force) and possibly repeat the test 2-3 times, with a break between different attempts, then going to calculate the average oh the kg moved with the dynamometer
Measured: evaluation of sarcopenia state through study completion, an average of 1 year
Skeletall mass fuctionality for sarcopenia definition
Functional parameters of skeletal muscle defined by the chair test: five-times sit-to-stand test; time duration 30-second chair stand test. You measure by considering the ability in seconds to get up and sit down from the chair properly
Measured: evaluation of sarcopenia state through study completion, an average of 1 year
Skeletall mass calculation for sarcopenia definition
The percentage of skeletal muscle mass relative to body mass will be considered.
Skeletal mass will be calculated as follows:
SM(Kg)=[(h^2/(BIA resistance)0.401)+(gender3.825)+(age*0.071)]+5.102 Where h indicates height measured in cm, gender is a dichotomous variable taking a value of 1 for males and 0 for females, and age is measured in years.
From this measurement, the percentage of skeletal muscle mass (%SMM) will be calculated:
%SMM=(SM (Kg))/(Body mass (Kg))*100
Measured: evaluation of sarcopenia state through study completion, an average of 1 year
Number of participants with sarcopenia
According to consensus statement of European Society for Clinical Nutrition and Metabolism (ESPEN) and dell' European Association for the Study of Obesity (EASO) guidelines, individuals with altered skeletal muscle functionality parameters (HGS < 16 kg for females and < 27 kg for males or chair test >15 seconds for both males and females [27]), altered %BF(body fat) (≥ 25% for males and ≥35% for females [28]), and altered %SMM (<35.6% (≤28.7% severe sarcopenia) for males, <28.4% (≤23% severe sarcopenia) for females) will be defined as sarcopenic.
Measured: evaluation of sarcopenia state through study completion, an average of 1 year
Advanced glycation end products quantification
AGE levels will be measured using skin fluorescence, using the "AGE reader mu" device (range from 1.3 to 5 level of AGEs respect to the patient's age).
Measured: evaluation of AGEs through study completion, an average of 1 year
Endogenous and exogenous AGEs plasma quantification
AGEs will also be assessed at the plasma level in free form (ELISA, fluorescence assay) or bound to hemoglobin (HbA1c clinical practice test), both measured in pg/mL
Measured: evaluation of AGEs through study completion, an average of 1 year
Secondary outcomes (9)
With questionnaires assessment of socio-demographic characteristics
Gender, date of birth, date of diabetes diagnosis (for diabetic subjects) are assessed through questionnaires and medical record
Measured: evaluation of socio-demographic characteristics through study completion, an average of 1 year
Anthropometric measurements
weight is assessed in Kg with the use of the bioimpedance balance
Measured: evaluation of weight and body composition through study completion, an average of 1 year
Anthropometric measurements
the height is measured in cm through a wall altimeter
Measured: evaluation of height through study completion, an average of 1 year
Anthropometric measurements
the BMI (body mass index) is calculated by making the ratio of the weight to the square of the height
Measured: evaluation of BMI (body mass index) through study completion, an average of 1 year
Anthropometric measurements
waist, hip, arm, and calf circumference are measured using an anelastic meter
Measured: evaluation of circumferences through study completion, an average of 1 year
Dietary Inflammatory Index (DII)
Calculated using Alternative Healthy Eating Index-2010 (AHEI-2010) derived from basal metabolism assessment through fasting morning indirect calorimetry.
Measured: evaluation of DII through study completion, an average of 1 year
Adherence level to the Western diet with European Prospective Investigation into Cancer and Nutrition (EPIC) questionnaires
Assessed with the use of questionnaire. EPIC is used for the bromatology evaluation of the diet, so there aren't scales but only indication about the macro and micronutrient composition. This is a qualitative questionnaires and not quantitative.
Measured: evaluation of DII through study completion, an average of 1 year
Adherence level to the Western diet with 24h recall questionnaires
Assessed with the use of questionnaires. 24h recall questionnaire is used for the bromatology evaluation of the diet, so there aren't scales but only indication about the macro and micronutrient composition. This is a qualitative questionnaires and not quantitative.
Measured: evaluation of DII through study completion, an average of 1 year
Level of physical activity, related to sarcopenia,using a questionnaire
Physical activity is assessed using the International Physical Activity Questionnaire (IPAQ), which provides results in Metabolic Equivalent of Tasks (METs). The questions refer to activities over the past 7 days, including work, transportation, and leisure time.
Moderate physical activity: Requires moderate effort and a slightly higher breathing rate than normal. One can speak but not sing during this activity.
Intense physical activity: Requires significant effort and a much higher breathing rate, causing sweating and making it difficult to talk.
The METs scale is as follows:
Less than 700 METs: Inactive 700 to 2519 METs: Sufficiently active More than 2520 METs: Active
Measured: evaluation of METs through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start15 Jun 2024
- Primary completion15 May 2026
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Flavia Prodam, Azienda Ospedaliero Universitaria Maggiore della Carita
- Investigators
- Flavia Prodam, MD PhD, Principal investigator, AOU Maggiore della Carità di Novara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06438900
- Sponsor's protocol ID
- CE049/2024
- Acronym
- Westernage
- Status last verified
- Oct 2026
- First submitted
- 14 May 2024
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Frontera WR, Ochala J. Skeletal muscle: a brief review of structure and function. Calcif Tissue Int. 2015 Mar;96(3):183-95. doi: 10.1007/s00223-014-9915-y. Epub 2014 Oct 8.
PubMed 25294644Merz KE, Thurmond DC. Role of Skeletal Muscle in Insulin Resistance and Glucose Uptake. Compr Physiol. 2020 Jul 8;10(3):785-809. doi: 10.1002/cphy.c190029.
PubMed 32940941Bonaldo P, Sandri M. Cellular and molecular mechanisms of muscle atrophy. Dis Model Mech. 2013 Jan;6(1):25-39. doi: 10.1242/dmm.010389.
PubMed 23268536Cohen S, Nathan JA, Goldberg AL. Muscle wasting in disease: molecular mechanisms and promising therapies. Nat Rev Drug Discov. 2015 Jan;14(1):58-74. doi: 10.1038/nrd4467.
PubMed 25549588Dutt V, Gupta S, Dabur R, Injeti E, Mittal A. Skeletal muscle atrophy: Potential therapeutic agents and their mechanisms of action. Pharmacol Res. 2015 Sep;99:86-100. doi: 10.1016/j.phrs.2015.05.010. Epub 2015 Jun 2.
PubMed 26048279Lecker SH, Jagoe RT, Gilbert A, Gomes M, Baracos V, Bailey J, Price SR, Mitch WE, Goldberg AL. Multiple types of skeletal muscle atrophy involve a common program of changes in gene expression. FASEB J. 2004 Jan;18(1):39-51. doi: 10.1096/fj.03-0610com.
PubMed 14718385Hosseini Z, Whiting SJ, Vatanparast H. Current evidence on the association of the metabolic syndrome and dietary patterns in a global perspective. Nutr Res Rev. 2016 Dec;29(2):152-162. doi: 10.1017/S095442241600007X.
PubMed 27955720Tsilingiris D, Tzeravini E, Koliaki C, Dalamaga M, Kokkinos A. The Role of Mitochondrial Adaptation and Metabolic Flexibility in the Pathophysiology of Obesity and Insulin Resistance: an Updated Overview. Curr Obes Rep. 2021 Sep;10(3):191-213. doi: 10.1007/s13679-021-00434-0. Epub 2021 Apr 10.
PubMed 33840072Peppa M, Mavroeidi I. Experimental Animal Studies Support the Role of Dietary Advanced Glycation End Products in Health and Disease. Nutrients. 2021 Sep 29;13(10):3467. doi: 10.3390/nu13103467.
PubMed 34684468Muthyalaiah YS, Jonnalagadda B, John CM, Arockiasamy S. Impact of Advanced Glycation End products (AGEs) and its receptor (RAGE) on cancer metabolic signaling pathways and its progression. Glycoconj J. 2021 Dec;38(6):717-734. doi: 10.1007/s10719-021-10031-x. Epub 2022 Jan 22.
PubMed 35064413Mori H, Kuroda A, Ishizu M, Ohishi M, Takashi Y, Otsuka Y, Taniguchi S, Tamaki M, Kurahashi K, Yoshida S, Endo I, Aihara KI, Funaki M, Akehi Y, Matsuhisa M. Association of accumulated advanced glycation end-products with a high prevalence of sarcopenia and dynapenia in patients with type 2 diabetes. J Diabetes Investig. 2019 Sep;10(5):1332-1340. doi: 10.1111/jdi.13014. Epub 2019 Feb 19.
PubMed 30677242Waqas K, Chen J, Trajanoska K, Ikram MA, Uitterlinden AG, Rivadeneira F, Zillikens MC. Skin Autofluorescence, a Noninvasive Biomarker for Advanced Glycation End-products, Is Associated With Sarcopenia. J Clin Endocrinol Metab. 2022 Jan 18;107(2):e793-e803. doi: 10.1210/clinem/dgab632.
PubMed 34453164Chiu CY, Yang RS, Sheu ML, Chan DC, Yang TH, Tsai KS, Chiang CK, Liu SH. Advanced glycation end-products induce skeletal muscle atrophy and dysfunction in diabetic mice via a RAGE-mediated, AMPK-down-regulated, Akt pathway. J Pathol. 2016 Feb;238(3):470-82. doi: 10.1002/path.4674. Epub 2015 Dec 31.
PubMed 26586640Chiappalupi S, Sorci G, Vukasinovic A, Salvadori L, Sagheddu R, Coletti D, Renga G, Romani L, Donato R, Riuzzi F. Targeting RAGE prevents muscle wasting and prolongs survival in cancer cachexia. J Cachexia Sarcopenia Muscle. 2020 Aug;11(4):929-946. doi: 10.1002/jcsm.12561. Epub 2020 Mar 11.
PubMed 32159297Egawa T, Tsuda S, Goto A, Ohno Y, Yokoyama S, Goto K, Hayashi T. Potential involvement of dietary advanced glycation end products in impairment of skeletal muscle growth and muscle contractile function in mice. Br J Nutr. 2017 Jan;117(1):21-29. doi: 10.1017/S0007114516004591. Epub 2017 Jan 17.
PubMed 28093090
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fighting Western-diet Derived AGEs to Mitigate Muscle Wasting in Sarcobesity:Observational Study on the Relationship Between AGE Levels and Sarcobesity in an Adult Population Affected by Obesity and Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06438900
- Acronym / sponsor ID
- Westernage / CE049/2024
- Conditions
- Sarcopenia, Obesity
- Keywords
- Advanced glycation end products, Sarcobesity, Obesity, Sarcopenic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della CaritaUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 3 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to explore whether a high level of AGEs (Advanced Glycation end products) derived from the diet may mediate diet-related muscle loss in Western-type diet, influencing the onset and progression of sarcopenia, predisposing to earlier and more severe metabolic consequences, including type 2 diabetes (T2D).
The primary objective of the study is to investigate how the accumulation of AGEs is correlated with muscle loss in adult patients with obesity and type 2 diabetes or lipodystrophy in order to identify possible targets to mitigate the metabolic alterations caused by the Western diet (WD). Specifically, circulating AGEs levels on the skin will be evaluated and correlated with the stage of sarcopenia in a group of patients with obesity and a T2D diagnosis. Furthermore, the relationship between disease duration and AGE levels will be assessed.
A secondary objective will be to analyze the clinical data obtained to identify metabolites and metabolic pathways responsible for the phenotype induced by the WD.
The ultimate aim of the study is therefore to verify whether high levels of AGEs are correlated with an early and/or more pronounced onset of sarcopenia, concurrently with an increase in inflammation and oxidative stress.
Detailed description
The study in question is of a cross-sectional observational type. The reference population is defined by patients with obesity and a diagnosis of T2D within 15 years of entry into the study or patients with concomitant type 2 diabetes and lipodystrophy syndrome. This population was chosen because they are at high risk of sarcopenia.
Lipodystrophy includes a heterogeneous spectrum of genetic and acquired diseases characterized by loss of subcutaneous adipose tissue, ectopic fat accumulation, insulin resistance, metabolic and cardiovascular diseases, premature aging, sarcopenia, muscle pain, high-grade inflammation, epigenetic dysregulation, and mitochondrial dysfunction. Therefore, patients with T2D and lipodystrophy are highly inflamed as they generally present with a more severe T2D phenotype, presumed sarcopenic, and with a high rate of endogenous AGE production. Patients with concurrent lipodystrophy and T2D will be recruited as sarcopenic and obese subjects, representing an excellent strategy for comparison with diabetic individuals without lipodystrophy.
SUBJECTS AND METHODS A total of 195 consecutive subjects will be enrolled in the study from the Endocrinology Unit of the University of Eastern Piedmont between April 2024 and April 2026, who meet the inclusion criteria.
Study duration:
The study will last for two years corresponding to the enrollment period given the cross-sectional nature of the study.
Statistical Analysis
Descriptive statistics will be used to summarize sociodemographic, anthropometric, clinical, and lifestyle-related information collected. Categorical variables will be summarized using absolute frequencies and percentages, while numerical variables will be summarized using mean and standard deviation or median and interquartile range if not normally distributed according to the Shapiro-Wilk test and after observation of Q-Q plots (quantile-quantile plot).
The Pearson correlation coefficient or the corresponding non-parametric Spearman rank correlation coefficient and confidence intervals will be initially calculated to assess the correlation between the levels of individual AGEs and skeletal muscle mass (SMM), handgrip strength (HGS), parameters of body composition, and functional parameters of skeletal muscle. Subsequently, linear regression models will be used to evaluate the relationship between AGEs and sarcopenia-defining indices adjusted for age, sex, duration of diabetes, and other potential confounding factors such as inflammation, adherence to the Western diet, and levels of physical activity. The LASSO method will be used for variable selection in multivariable regression models.
Univariable and multivariable Poisson regression models with robust variance will be used to estimate relative prevalence risks for the association between AGEs and patient characteristics with sarcopenia presence and the corresponding confidence intervals.
An integration of clinical data, biochemical data, AGE levels, and patient omic signatures will be performed to develop a multifactorial diagnostic model using multivariate statistical analysis (e.g., factor analysis, principal component analysis, cluster analysis, discriminant analysis, partial least squares analysis, logistic regression) and data-driven approaches. Machine learning algorithms will be applied to prioritize and weigh risk factors. These analyses will be conducted with internal statistical consultation already utilized by the group.
Expected Results
With this study, the investigators expect to obtain further information and correlations between nutritional assessment and its impact on inflammation, sarcopenia definition, and progression, obesity, and T2D, based on body measurements and clinical parameters. Through biochemical, hormonal, and metabolomic analyses conducted on biological samples, te investigators expect to identify possible markers related to the presence of AGEs. In conclusion, the primary expected outcome would be to identify a positive correlation between AGE accumulation in at least one compartment (skin, plasma, urine) and the severity of sarcopenia, thus obtaining a rapid and non-invasive method to identify individuals at high risk of developing muscle wasting (MW) and identify correlations between AGE levels and other metabolic characteristics, even in lipodystrophic pathology.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Given a type I error rate (α) of 0.05 and a power of 80%, 195 subjects will be needed to observe a significant correlation between AGE levels and sarcobesity indices of at least 0.2. Considering the low prevalence of lipodystrophy and a recruitment duration of one year, approximately 35 subjects with this condition are expected to be included. The remaining 160 subjects will have diabetes and obesity. Furthermore, considering that the duration of diabetes may influence AGE levels and sarcobesity, both subjects with long-standing diabetes (80 patients) and those with less than one year of diagnosis (80 patients) will be selected, which can be considered comparable to subjects in pre-diabetes.
Key inclusion criteria (3 listed)
- Patients of both sexes.
- Adults.
- BMI compatible with obesity and a diagnosis of type 2 diabetes under good metabolic control (HbA1c < 7.5%) within 15 years of entry into the study or diagnosis of lipodystrophy (included in the European Consortium of Lipodystrophies (ECLip) Registry (eclip-web.org))
Key exclusion criteria (4 listed)
- Age under 18 years.
- Secondary obesity or genetic diseases (Prader-Willi Syndrome, Down Syndrome); metabolic and endocrine disorders (Cushing's syndrome, hypothyroidism).
- Subjects with: Inflammatory Bowel Disease (IBD), cancer.
- Confirmed or planned pregnancy during the study participation months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Skeletal mass functionality for sarcopenia definition
Time frame: evaluation of sarcopenia state through study completion, an average of 1 year
Functional parameters of skeletal muscle defined by muscle strength measured through hand grip strength (HGS) The test requires the patient to tighten the handle the dynamometer with the maximum possible force, then maintaining the contraction for at least 5 seconds; you should repeat the test on the other hand (it is normal that the dominant expresses a higher force) and possibly repeat the test 2-3 times, with a break between different attempts, then going to calculate the average oh the kg moved with the dynamometer
Skeletall mass fuctionality for sarcopenia definition
Time frame: evaluation of sarcopenia state through study completion, an average of 1 year
Functional parameters of skeletal muscle defined by the chair test: five-times sit-to-stand test; time duration 30-second chair stand test. You measure by considering the ability in seconds to get up and sit down from the chair properly
Skeletall mass calculation for sarcopenia definition
Time frame: evaluation of sarcopenia state through study completion, an average of 1 year
The percentage of skeletal muscle mass relative to body mass will be considered. Skeletal mass will be calculated as follows: SM(Kg)=[(h^2/(BIA resistance)0.401)+(gender3.825)+(age*0.071)]+5.102 Where h indicates height measured in cm, gender is a dichotomous variable taking a value of 1 for males and 0 for females, and age is measured in years. From this measurement, the percentage of skeletal muscle mass (%SMM) will be calculated: %SMM=(SM (Kg))/(Body mass (Kg))*100
Number of participants with sarcopenia
Time frame: evaluation of sarcopenia state through study completion, an average of 1 year
According to consensus statement of European Society for Clinical Nutrition and Metabolism (ESPEN) and dell' European Association for the Study of Obesity (EASO) guidelines, individuals with altered skeletal muscle functionality parameters (HGS < 16 kg for females and < 27 kg for males or chair test >15 seconds for both males and females [27]), altered %BF(body fat) (≥ 25% for males and ≥35% for females [28]), and altered %SMM (<35.6% (≤28.7% severe sarcopenia) for males, <28.4% (≤23% severe sarcopenia) for females) will be defined as sarcopenic.
Advanced glycation end products quantification
Time frame: evaluation of AGEs through study completion, an average of 1 year
AGE levels will be measured using skin fluorescence, using the "AGE reader mu" device (range from 1.3 to 5 level of AGEs respect to the patient's age).
Endogenous and exogenous AGEs plasma quantification
Time frame: evaluation of AGEs through study completion, an average of 1 year
AGEs will also be assessed at the plasma level in free form (ELISA, fluorescence assay) or bound to hemoglobin (HbA1c clinical practice test), both measured in pg/mL
9 secondary outcomes
With questionnaires assessment of socio-demographic characteristics
Time frame: evaluation of socio-demographic characteristics through study completion, an average of 1 year
Anthropometric measurements
Time frame: evaluation of weight and body composition through study completion, an average of 1 year
Anthropometric measurements
Time frame: evaluation of height through study completion, an average of 1 year
Anthropometric measurements
Time frame: evaluation of BMI (body mass index) through study completion, an average of 1 year
Anthropometric measurements
Time frame: evaluation of circumferences through study completion, an average of 1 year
Dietary Inflammatory Index (DII)
Time frame: evaluation of DII through study completion, an average of 1 year
Adherence level to the Western diet with European Prospective Investigation into Cancer and Nutrition (EPIC) questionnaires
Time frame: evaluation of DII through study completion, an average of 1 year
Adherence level to the Western diet with 24h recall questionnaires
Time frame: evaluation of DII through study completion, an average of 1 year
Level of physical activity, related to sarcopenia,using a questionnaire
Time frame: evaluation of METs through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Background: PubMed 25294644Frontera WR, Ochala J. Skeletal muscle: a brief review of structure and function. Calcif Tissue Int. 2015 Mar;96(3):183-95. doi: 10.1007/s00223-014-9915-y. Epub 2014 Oct 8.
- Background: PubMed 32940941Merz KE, Thurmond DC. Role of Skeletal Muscle in Insulin Resistance and Glucose Uptake. Compr Physiol. 2020 Jul 8;10(3):785-809. doi: 10.1002/cphy.c190029.
- Background: PubMed 23268536Bonaldo P, Sandri M. Cellular and molecular mechanisms of muscle atrophy. Dis Model Mech. 2013 Jan;6(1):25-39. doi: 10.1242/dmm.010389.
- Background: PubMed 25549588Cohen S, Nathan JA, Goldberg AL. Muscle wasting in disease: molecular mechanisms and promising therapies. Nat Rev Drug Discov. 2015 Jan;14(1):58-74. doi: 10.1038/nrd4467.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Flavia Prodam, MD PhD principal investigator
AOU Maggiore della Carità di Novara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Obesity, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Flavia Prodam, MD PhD (+39-0321-660693, flavia.prodam@med.uniupo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal mass functionality for sarcopenia definition (time frame: evaluation of sarcopenia state through study completion, an average of 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06438900, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.