Type 2 DiabetesDIABESTNCT06057246
Individual Determinants of Postprandial Glucose Response in Type 2 Diabetes
A study testing Test meal with postprandial samples in people with Type 2 Diabetes, run by Federico II University at 1 site in Italy.
Trial summary
Postprandial glycemia (PPG) is a relevant determinant of glucose control in people with type 2 diabetes (T2D). Epidemiological and pathophysiological studies indicate that PPG is a better risk predictor for cardiovascular disease and all-cause mortality than fasting plasma glucose. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Test meal with postprandial samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteItaly
- Study dates
- 15 May 2023to May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and post-menopausal women
- HbA1c ≤ 7.5%
- Body Mass Index (BMI) 20-39.9 kg/m2
- Ability to comply with the study protocol activities.
Who cannot join
- Any acute or chronic condition possibly influencing the interpretation of the results or possibly worsened because of study participation
- Pregnancy or breast-feeding
- Use of antibiotics, probiotics, or prebiotics during the last three months.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Department of Clinical Medicine and Surgery Federico II University
Naples, 80131
Angela A Rivellese, Professor, 00397473665
About this study
Official title: Exploring Individual Determinants of postpranDIAl Glucose Response in Type 2 diaBEteS to opTimize Therapeutic Strategies With a Personalized Approach (DIABEST)
Postprandial glycemia (PPG) is a relevant determinant of glucose control in people with type 2 diabetes (T2D). Epidemiological and pathophysiological studies indicate that PPG is a better risk predictor for cardiovascular disease and all-cause mortality than fasting plasma glucose. Therefore, both fasting and postprandial glycemia should be targeted to achieve optimal glycemic control and, thus, prevent or reduce the risk of diabetes complications.
Post-prandial glucose response (PGR) cannot be predicted based solely on the meals' carbohydrate content. Recent research using continuous glucose monitoring (CGM) systems has identified different patterns of PGR to a standard meal among both healthy people and individuals with type 1 diabetes. Different contributors to the PGR have emerged, including genotype, hormonal and metabolic factors, phenotype, gut microbiota composition, background diet, sleep habits, physical activity levels.
Read more
The present project aims at exploring the PGR in a real-life setting in a cohort of people with T2D, and identifying person-specific factors associated with different postprandial glucose patterns.
To this purpose, 144 individuals with T2D on treatment with diet alone or diet plus metformin will be characterized for their anthropometric, metabolic, and gut-microbiome features and will undergo a one-week observational period through CGM system, while properly recording their food intake, physical activity, and sleep habits. A mixed-nutrient standardized meal will be consumed at home in two occasions by each participant to investigate the intra-individual variability of the PGR. Moreover, in a subgroup of participants (n=60), divided according to anthropometric and metabolic features, hormonal and metabolic response to the standardized meal will be evaluated at the hospital, to explore the contribution of different T2D phenotypes to the PGR.
A further step will be developing a prediction algorithm of PGR based on the intra- and inter-individual factors shown to influence postprandial glucose, able to further optimize the management of T2D with precision therapeutic strategies.
Read the detailed description
The participants will undergo a 7-day observational period and acute postprandial tests with a standardized meal. Before the study initiation, all participants will undergo a screening visit for the assessment of inclusion and exclusion criteria. Participants meeting the inclusion criteria will be instructed to collect a stool sample and will be scheduled for the experimental visit (day 0). At day 0, each participant will arrive at the diabetes clinic in the morning, after a 10-hour fasting, to undergo:
- venous blood sampling for biochemical determinations
- anthropometrics and blood pressure measurements
- body composition evaluation (bioimpedance analysis)
- basal metabolic rate evaluation (indirect calorimetry)
- administrations of questionnaires for the evaluation of lifestyle habits
- positioning of a subcutaneous sensor for continuous glucose monitoring (CGM).
Information regarding characteristics of bowel movements in the day of stool sampling will be collected according to the Bristol stool scale.
The participants will be instructed to consume at home a mixed-nutrient meal at breakfast on the second day and on the last day of the observational period. PGR will be assessed by CGM.
Over the following 7 days, participants will undergo CGM while keeping stable their own dietary and lifestyle habits and will be asked to record the following information by using a dedicated app:
- a 7-day food diary reporting all foods and drinks consumed, including dressing, portions by household measures (cup, spoons, etc.) or weight, and providing as much details as possible (i.e., cooking methods, brands names). Seven-day food records will be discussed with a skilled dietitian to check potential mistakes and missing information. Energy intake and dietary composition (nutrients and non-nutrients), and food groups consumption will be calculated using the Food Composition Database for epidemiological Studies in Italy of the European Institute of Oncology;
- any stressful event or drug assumption.
In parallel, during the 7-day observational period, data on physical activity levels and sleep habits will be collected by using an accelerometer (Actigraph medical device).
At the 8th day, a subgroup of 60 participants (20 with prevalent impairment of insulin sensitivity, 20 with prevalent impairment of insulin secretion, and 20 with prevalent visceral obesity - as determined by anthropometrics, fasting C-peptide, and plasma triglycerides) will return to the hospital and consume the same standardized meal consumed at home. Before and over 4 hours after the meal, venous blood samples will be collected at fixed time points for biochemical evaluations.
CGM data from 30 min before meal to 6 h after meal will be analyzed. Postprandial blood glucose changes will be calculated with the trapezoidal method as the incremental area under the curve above the baseline value (iAUC). Predictors of early blood glucose response (iAUC0-3h), late blood glucose response (iAUC3-6h), total blood glucose response (iAUC0-6h), and, as indicator of time-course of the blood glucose changes, the difference between late and early response (iAUC3-6h minus 0-3h) will be evaluated using mixed-effect linear regression considering the patient's identification number (ID) as a random effect. To evaluate the significance of the random-effect factor, ANOVA will be used to test for the difference between the model with and without the random effect.
- Conditions
- Type 2 Diabetes
- Being tested
- Test meal with postprandial samples
- Keywords
- Post-prandial glucose response, Personalized nutrition, Personalized therapeutic strategies, Continuous glucose monitoring, Gut microbiota
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test meal with postprandial samplesOther
The mixed-nutrient test meal consists of a sandwich made with bread, spread cheese, air-cured beef, and one apple. Nutritional composition of the meal will be: total energy (TE) content 532 kcal, carbohydrates 68,4 g (49.3% TE), total fat 17.1 g (29.5% TE), protein 27.8 g (21.4% TE), and fibre 6 g. Before and over 4 hours after the meal, venous blood samples will be taken for biochemical evaluations at the time points -15'; 0'; 15'; 30'; 60'; 120'; 180'; 240'.
| Study group | Role | What they receive |
|---|---|---|
| Men and post-menopausal women with type 2 diabetes on treatment with diet or diet plus metformin | Experimental | Each participant will undergo anthropometrics and blood pressure measurements, bioimpedance analysis, indirect calorimetry, administrations of questionnaires for the evaluation of lifestyle habits, 7 days continuous glucose monitoring in parallel with diet, physical activity and sleep monitoring, and standard mixed-nutrient meals at home; a subgroup of 60 participants will undergo venous blood sampling for biochemical determinations before and after a standard mixed-nutrient meal. Receives: Other: Test meal with postprandial samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-prandial glucose response
Post-prandial glucose response will be calculated by the trapezoidal method as the area under the curve above the baseline value (iAUC).
Measured: 7 days (related to the 7-day continuous glucose monitoring)
Secondary outcomes (5)
Energy intake
The energy intake expressed in kilocalories and derived by the analysis of the 7-day food record plus the European Prospective Investigation into Cancer and Nutrition (EPIC) questionnaire will be evaluated in relation to the post-prandial glucose response (iAUC).
Measured: 7 days (related to the 7-day continuous glucose monitoring and food record)
Dietary components
The dietary components, namely available carbohydrates, total proteins, animal proteins, plant proteins, total fats, saturated fats, mono- and polyunsaturated fats, fibre and sugars (all expressed in grams), will be derived by the analysis of the 7-day food record and the (European Prospective Investigation into Cancer and Nutrition (EPIC) questionnaire, and evaluated in relation to the to the post-prandial glucose response (iAUC).
Measured: 7 days (related to the 7-day continuous glucose monitoring and food record)
Gut-microbiota composition
Gut microbiota composition will be assessed using relative bacterial taxonomic abundances and measures of community diversity and richness (derived from 16 S ribosomal ribonucleic acid (rRNA) high-throughput sequencing of baseline stool specimens), and will be evaluated in relation to the post-prandial glucose response (iAUC).
Measured: 7 days (related to the 7-day continuous glucose monitoring)
Physical activity levels
Physical activity levels as detected by the ActiGraph device (GT3X+ActiGraph LLC, Pensacola, Florida; sampling frequency: 30 Hz) worn for 7 days on the non-dominant wrist, and expressed as % of time spent in sedentary-light-moderate activity will be evaluated in relation to the post-prandial glucose response (iAUC).
Measured: 7 days (related to the 7-day continuous glucose and physical activity monitoring)
Sleep duration
Sleep metrics, namely total sleep time, sleep onset latency, wake after sleep onset (all measured in minutes), as detected by ActiGraph device worn for 7 days and nights and calculated by the software (ActiGraph LLC, Pensacola, Florida; version 6.13.4), will be evaluated in relation to the post-prandial glucose response (iAUC).
Measured: 7 days (related to the 7-day continuous glucose and sleep monitoring)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start15 May 2023
- Primary completionSep 2024 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rivellese angela, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057246
- Sponsor's protocol ID
- 31/2023
- Acronym
- DIABEST
- Status last verified
- Oct 2023
- First submitted
- 19 Jul 2023
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hall H, Perelman D, Breschi A, Limcaoco P, Kellogg R, McLaughlin T, Snyder M. Glucotypes reveal new patterns of glucose dysregulation. PLoS Biol. 2018 Jul 24;16(7):e2005143. doi: 10.1371/journal.pbio.2005143. eCollection 2018 Jul.
PubMed 30040822Shilo S, Godneva A, Rachmiel M, Korem T, Kolobkov D, Karady T, Bar N, Wolf BC, Glantz-Gashai Y, Cohen M, Zuckerman Levin N, Shehadeh N, Gruber N, Levran N, Koren S, Weinberger A, Pinhas-Hamiel O, Segal E. Prediction of Personal Glycemic Responses to Food for Individuals With Type 1 Diabetes Through Integration of Clinical and Microbial Data. Diabetes Care. 2022 Mar 1;45(3):502-511. doi: 10.2337/dc21-1048.
PubMed 34711639Bozzetto L, Pacella D, Cavagnuolo L, Capuano M, Corrado A, Scida G, Costabile G, Rivellese AA, Annuzzi G. Postprandial glucose variability in type 1 diabetes: The individual matters beyond the meal. Diabetes Res Clin Pract. 2022 Oct;192:110089. doi: 10.1016/j.diabres.2022.110089. Epub 2022 Sep 17.
PubMed 36122866Zeevi D, Korem T, Zmora N, Israeli D, Rothschild D, Weinberger A, Ben-Yacov O, Lador D, Avnit-Sagi T, Lotan-Pompan M, Suez J, Mahdi JA, Matot E, Malka G, Kosower N, Rein M, Zilberman-Schapira G, Dohnalova L, Pevsner-Fischer M, Bikovsky R, Halpern Z, Elinav E, Segal E. Personalized Nutrition by Prediction of Glycemic Responses. Cell. 2015 Nov 19;163(5):1079-1094. doi: 10.1016/j.cell.2015.11.001.
PubMed 26590418Berry SE, Valdes AM, Drew DA, Asnicar F, Mazidi M, Wolf J, Capdevila J, Hadjigeorgiou G, Davies R, Al Khatib H, Bonnett C, Ganesh S, Bakker E, Hart D, Mangino M, Merino J, Linenberg I, Wyatt P, Ordovas JM, Gardner CD, Delahanty LM, Chan AT, Segata N, Franks PW, Spector TD. Human postprandial responses to food and potential for precision nutrition. Nat Med. 2020 Jun;26(6):964-973. doi: 10.1038/s41591-020-0934-0. Epub 2020 Jun 11.
PubMed 32528151
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Individual Determinants of postpranDIAl Glucose Response in Type 2 diaBEteS to opTimize Therapeutic Strategies With a Personalized Approach (DIABEST)
- ClinicalTrials.gov ID
- NCT06057246
- Acronym / sponsor ID
- DIABEST / 31/2023
- Conditions
- Type 2 Diabetes
- Keywords
- Post-prandial glucose response, Personalized nutrition, Personalized therapeutic strategies, Continuous glucose monitoring, Gut microbiota
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 28 Sep 2023 (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.
Postprandial glycemia (PPG) is a relevant determinant of glucose control in people with type 2 diabetes (T2D). Epidemiological and pathophysiological studies indicate that PPG is a better risk predictor for cardiovascular disease and all-cause mortality than fasting plasma glucose. Therefore, both fasting and postprandial glycemia should be targeted to achieve optimal glycemic control and, thus, prevent or reduce the risk of diabetes complications.
Post-prandial glucose response (PGR) cannot be predicted based solely on the meals' carbohydrate content. Recent research using continuous glucose monitoring (CGM) systems has identified different patterns of PGR to a standard meal among both healthy people and individuals with type 1 diabetes. Different contributors to the PGR have emerged, including genotype, hormonal and metabolic factors, phenotype, gut microbiota composition, background diet, sleep habits, physical activity levels.
The present project aims at exploring the PGR in a real-life setting in a cohort of people with T2D, and identifying person-specific factors associated with different postprandial glucose patterns.
To this purpose, 144 individuals with T2D on treatment with diet alone or diet plus metformin will be characterized for their anthropometric, metabolic, and gut-microbiome features and will undergo a one-week observational period through CGM system, while properly recording their food intake, physical activity, and sleep habits. A mixed-nutrient standardized meal will be consumed at home in two occasions by each participant to investigate the intra-individual variability of the PGR. Moreover, in a subgroup of participants (n=60), divided according to anthropometric and metabolic features, hormonal and metabolic response to the standardized meal will be evaluated at the hospital, to explore the contribution of different T2D phenotypes to the PGR.
A further step will be developing a prediction algorithm of PGR based on the intra- and inter-individual factors shown to influence postprandial glucose, able to further optimize the management of T2D with precision therapeutic strategies.
Detailed description
The participants will undergo a 7-day observational period and acute postprandial tests with a standardized meal. Before the study initiation, all participants will undergo a screening visit for the assessment of inclusion and exclusion criteria. Participants meeting the inclusion criteria will be instructed to collect a stool sample and will be scheduled for the experimental visit (day 0). At day 0, each participant will arrive at the diabetes clinic in the morning, after a 10-hour fasting, to undergo:
- venous blood sampling for biochemical determinations
- anthropometrics and blood pressure measurements
- body composition evaluation (bioimpedance analysis)
- basal metabolic rate evaluation (indirect calorimetry)
- administrations of questionnaires for the evaluation of lifestyle habits
- positioning of a subcutaneous sensor for continuous glucose monitoring (CGM).
Information regarding characteristics of bowel movements in the day of stool sampling will be collected according to the Bristol stool scale.
The participants will be instructed to consume at home a mixed-nutrient meal at breakfast on the second day and on the last day of the observational period. PGR will be assessed by CGM.
Over the following 7 days, participants will undergo CGM while keeping stable their own dietary and lifestyle habits and will be asked to record the following information by using a dedicated app:
- a 7-day food diary reporting all foods and drinks consumed, including dressing, portions by household measures (cup, spoons, etc.) or weight, and providing as much details as possible (i.e., cooking methods, brands names). Seven-day food records will be discussed with a skilled dietitian to check potential mistakes and missing information. Energy intake and dietary composition (nutrients and non-nutrients), and food groups consumption will be calculated using the Food Composition Database for epidemiological Studies in Italy of the European Institute of Oncology;
- any stressful event or drug assumption.
In parallel, during the 7-day observational period, data on physical activity levels and sleep habits will be collected by using an accelerometer (Actigraph medical device).
At the 8th day, a subgroup of 60 participants (20 with prevalent impairment of insulin sensitivity, 20 with prevalent impairment of insulin secretion, and 20 with prevalent visceral obesity - as determined by anthropometrics, fasting C-peptide, and plasma triglycerides) will return to the hospital and consume the same standardized meal consumed at home. Before and over 4 hours after the meal, venous blood samples will be collected at fixed time points for biochemical evaluations.
CGM data from 30 min before meal to 6 h after meal will be analyzed. Postprandial blood glucose changes will be calculated with the trapezoidal method as the incremental area under the curve above the baseline value (iAUC). Predictors of early blood glucose response (iAUC0-3h), late blood glucose response (iAUC3-6h), total blood glucose response (iAUC0-6h), and, as indicator of time-course of the blood glucose changes, the difference between late and early response (iAUC3-6h minus 0-3h) will be evaluated using mixed-effect linear regression considering the patient's identification number (ID) as a random effect. To evaluate the significance of the random-effect factor, ANOVA will be used to test for the difference between the model with and without the random effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Men and post-menopausal women with type 2 diabetes on treatment with diet or diet plus metformin | Experimental | Other: Test meal with postprandial samplesEach participant will undergo anthropometrics and blood pressure measurements, bioimpedance analysis, indirect calorimetry, administrations of questionnaires for the evaluation of lifestyle habits, 7 days continuous glucose monitoring in parallel with diet, physical activity and sleep monitoring, and standard mixed-nutrient meals at home; a subgroup of 60 participants will undergo venous blood sampling for biochemical determinations before and after a standard mixed-nutrient meal. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and post-menopausal women
- HbA1c ≤ 7.5%
- Body Mass Index (BMI) 20-39.9 kg/m2
- Ability to comply with the study protocol activities.
Key exclusion criteria (3 listed)
- Any acute or chronic condition possibly influencing the interpretation of the results or possibly worsened because of study participation
- Pregnancy or breast-feeding
- Use of antibiotics, probiotics, or prebiotics during the last three months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test meal with postprandial samplesThe mixed-nutrient test meal consists of a sandwich made with bread, spread cheese, air-cured beef, and one apple. Nutritional composition of the meal will be: total energy (TE) content 532 kcal, carbohydrates 68,4 g (49.3% TE), total fat 17.1 g (29.5% TE), protein 27.8 g (21.4% TE), and fibre 6 g. Before and over 4 hours after the meal, venous blood samples will be taken for biochemical evaluations at the time points -15'; 0'; 15'; 30'; 60'; 120'; 180'; 240'. | Other | Men and post-menopausal women with type 2 diabetes on treatment with diet or diet plus metformin |
Primary outcome
Post-prandial glucose response
Time frame: 7 days (related to the 7-day continuous glucose monitoring)
Post-prandial glucose response will be calculated by the trapezoidal method as the area under the curve above the baseline value (iAUC).
5 secondary outcomes
Energy intake
Time frame: 7 days (related to the 7-day continuous glucose monitoring and food record)
Dietary components
Time frame: 7 days (related to the 7-day continuous glucose monitoring and food record)
Gut-microbiota composition
Time frame: 7 days (related to the 7-day continuous glucose monitoring)
Physical activity levels
Time frame: 7 days (related to the 7-day continuous glucose and physical activity monitoring)
Sleep duration
Time frame: 7 days (related to the 7-day continuous glucose and sleep monitoring)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Results publication: PubMed 30040822Hall H, Perelman D, Breschi A, Limcaoco P, Kellogg R, McLaughlin T, Snyder M. Glucotypes reveal new patterns of glucose dysregulation. PLoS Biol. 2018 Jul 24;16(7):e2005143. doi: 10.1371/journal.pbio.2005143. eCollection 2018 Jul.
- Results publication: PubMed 34711639Shilo S, Godneva A, Rachmiel M, Korem T, Kolobkov D, Karady T, Bar N, Wolf BC, Glantz-Gashai Y, Cohen M, Zuckerman Levin N, Shehadeh N, Gruber N, Levran N, Koren S, Weinberger A, Pinhas-Hamiel O, Segal E. Prediction of Personal Glycemic Responses to Food for Individuals With Type 1 Diabetes Through Integration of Clinical and Microbial Data. Diabetes Care. 2022 Mar 1;45(3):502-511. doi: 10.2337/dc21-1048.
- Results publication: PubMed 36122866Bozzetto L, Pacella D, Cavagnuolo L, Capuano M, Corrado A, Scida G, Costabile G, Rivellese AA, Annuzzi G. Postprandial glucose variability in type 1 diabetes: The individual matters beyond the meal. Diabetes Res Clin Pract. 2022 Oct;192:110089. doi: 10.1016/j.diabres.2022.110089. Epub 2022 Sep 17.
- Results publication: PubMed 26590418Zeevi D, Korem T, Zmora N, Israeli D, Rothschild D, Weinberger A, Ben-Yacov O, Lador D, Avnit-Sagi T, Lotan-Pompan M, Suez J, Mahdi JA, Matot E, Malka G, Kosower N, Rein M, Zilberman-Schapira G, Dohnalova L, Pevsner-Fischer M, Bikovsky R, Halpern Z, Elinav E, Segal E. Personalized Nutrition by Prediction of Glycemic Responses. Cell. 2015 Nov 19;163(5):1079-1094. doi: 10.1016/j.cell.2015.11.001.
- Results publication: PubMed 32528151Berry SE, Valdes AM, Drew DA, Asnicar F, Mazidi M, Wolf J, Capdevila J, Hadjigeorgiou G, Davies R, Al Khatib H, Bonnett C, Ganesh S, Bakker E, Hart D, Mangino M, Merino J, Linenberg I, Wyatt P, Ordovas JM, Gardner CD, Delahanty LM, Chan AT, Segata N, Franks PW, Spector TD. Human postprandial responses to food and potential for precision nutrition. Nat Med. 2020 Jun;26(6):964-973. doi: 10.1038/s41591-020-0934-0. Epub 2020 Jun 11.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test meal with postprandial samples in people with Type 2 Diabetes, run by Federico II University 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 11 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Angela A Rivellese, Professor (00390817463665, rivelles@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-prandial glucose response (time frame: 7 days (related to the 7-day continuous glucose monitoring)). 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 NCT06057246, which also lists 5 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 11 Oct 2023.