Individual Determinants of Postprandial Glucose Response in Type 2 Diabetes

NCT06057246 | Unknown

• 1 other identifier: 31/2023
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Type 2 Diabetes

Keywords

Post-prandial glucose response; Personalized nutrition; Personalized therapeutic strategies; Continuous glucose monitoring; Gut microbiota

Outcome Measures

Primary Outcomes (1)

• 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).

  7 days (related to the 7-day continuous glucose monitoring)

Secondary Outcomes (5)

• Energy intake

  7 days (related to the 7-day continuous glucose monitoring and food record)

• Dietary components

  7 days (related to the 7-day continuous glucose monitoring and food record)

• Gut-microbiota composition

  7 days (related to the 7-day continuous glucose monitoring)

• Physical activity levels

  7 days (related to the 7-day continuous glucose and physical activity monitoring)

• Sleep duration

  7 days (related to the 7-day continuous glucose and sleep monitoring)

Study Arms (1)

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.

Other: Test meal with postprandial samples

Interventions

Test meal with postprandial samples OTHER

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'.

Men and post-menopausal women with type 2 diabetes on treatment with diet or diet plus metformin

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Department of Clinical Medicine and Surgery Federico II University

Naples, 80131, Italy

RECRUITING

Related Publications (5)

• 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.

  PMID: 30040822 RESULT

• Shilo 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.

  PMID: 34711639 RESULT

• Bozzetto 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.

  PMID: 36122866 RESULT

• Zeevi 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.

  PMID: 26590418 RESULT

• Berry 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.

  PMID: 32528151 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Angela A Rivellese, Professor

CONTACT

00390817463665; rivelles@unina.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: September 28, 2023
• Study Start: May 15, 2023
• Primary Completion: September 1, 2024
• Study Completion: May 1, 2025
• Last Updated: October 11, 2023

Record last verified: 2023-10

Locations

IT (1)