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Mathematical Modeling of Blood Sugar and Hormone Responses in Insulin-Dependent Type 2 Diabetes (MT2D)

12 juni 2026 bijgewerkt door: Clinical Nutrition Research Center, Illinois Institute of Technology

Mathematical Modeling of Type 2 Diabetes Mellitus

This observational study aims to collect detailed metabolic and physiologic data from adults with insulin-dependent type 2 diabetes mellitus following consumption of a mixed meal tolerance test. Participants will undergo frequent blood sampling over a 4-hour period after consuming a standardized liquid mixed meal to measure glucose, insulin, glucagon, C-peptide, and triglyceride responses. Participants will also use continuous glucose monitoring and wearable physical activity tracking devices during free-living conditions.

The purpose of this study is to develop mathematical models and digital representations ("digital twins") of people with type 2 diabetes mellitus. These models may help researchers better understand metabolic responses to meals, physical activity, and diabetes treatments, and may support future development of personalized diabetes technologies and therapies.

Studie Overzicht

Toestand

Werving

Conditie

Gedetailleerde beschrijving

Participants will first complete a screening visit at the Clinical Nutrition Research Center (CNRC) at the Illinois Institute of Technology. Screening procedures include assessment of medical history, dietary habits, physical activity history, body measurements, vital signs, glycated hemoglobin (HbA1c), and evaluation of eligibility criteria. Eligible participants will receive a continuous glucose monitor (CGM) and wearable activity tracker and will complete dietary recall assessments during the outpatient monitoring period.

Participants will undergo approximately 8 days of outpatient monitoring using continuous glucose monitoring and wearable physical activity tracking devices during free-living conditions. During this period, participants will continue their usual diabetes management and daily activities while recording dietary intake and medication use.

Participants will then complete an in-clinic Liquid Meal Test (LMT) visit following an overnight fast. During the study-day visit, an indwelling intravenous catheter will be placed for repeated venous blood collection. Blood samples will be collected before and over a 4-hour period after consumption of a standardized liquid meal consisting of vanilla-flavored Ensure®. Plasma measurements will include glucose, insulin, glucagon, C-peptide, and triglycerides. Participants will remain seated and monitored throughout the study visit, and safety assessments will be performed before discharge.

The information collected from continuous glucose monitoring, wearable activity tracking, dietary assessments, and repeated blood sampling will be used to develop mathematical models capable of simulating physiologic and metabolic responses in individuals with insulin-dependent type 2 diabetes mellitus. These models may contribute to future research focused on personalized diabetes management, optimization of therapeutic strategies, and evaluation of diabetes technologies.

Studietype

Observationeel

Inschrijving (Geschat)

25

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • Illinois
      • Chicago, Illinois, Verenigde Staten, 60616
        • Werving
        • Illinois Institute of Technology
        • Contact:
        • Hoofdonderzoeker:
          • Indika Edirisinghe, PhD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Adults 18 to 65 years of age with insulin-dependent type 2 diabetes mellitus will be recruited from the Illinois Institute of Technology Clinical Nutrition Research Center proprietary database, online advertisements, social media, community outreach, and local flyers. Eligible participants must be willing to undergo continuous glucose monitoring, wearable activity tracking, dietary assessment, overnight fasting, repeated blood collection, and a liquid meal tolerance test.

Beschrijving

Inclusion Criteria:

  • Men or women, 18-65 years of age
  • Diagnosed with insulin-dependent type 2 diabetes mellitus HbA1c ≥ 6.5% at screening
  • Current insulin therapy for ≥ 6 months prior to screening
  • Nonsmokers (past smokers can be allowed if they have abstained for a minimum of 12 months)
  • Judged to be in good health based on medical history (i.e., no clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal, or hepatic disease)
  • Able to provide informed consent
  • Able to comply with and perform the procedures requested by the protocol (including dietary restrictions, consumption of study foods, records of food diary, sample collection procedures, and study visit schedule)

Exclusion Criteria:

  • Men and women with known or suspected intolerance, allergies, or hypersensitivity to study foods
  • Men and women with low hemoglobin (Hgb) levels below 9.5 g/dL at the screening visit, indicating anemia
  • Men and women with blood pressure >160 mmHg (systolic) / 100 mmHg (diastolic) at the screening visit
  • Women who are pregnant or planning to become pregnant during the study
  • Major trauma or a surgical event within 2 months (or longer depending on trauma or event) and after consultation with PI.
  • Vegan or other extreme dietary regimens (e.g., Atkins diet, etc.) as judged by the investigator
  • History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional
  • Donated blood within the last 3 months
  • Unstable weight: gained or lost weight +/- 5 kg (11 lbs) in previous 2 months
  • Unusual working hours i.e., working overnight (e.g. 3rd shift)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Adults With Insulin-Dependent Type 2 Diabetes Mellitus
Adults 18 to 65 years of age with insulin-dependent type 2 diabetes mellitus who will undergo a liquid meal tolerance test with frequent blood sampling over 4 hours following consumption of a standardized liquid meal. Participants will also undergo outpatient continuous glucose monitoring and wearable physical activity tracking during free-living conditions to support mathematical modeling of metabolic and physiologic responses.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Plasma Glucose Concentration (mg/dL)
Tijdsspanne: -10 to 240 minutes relative to meal consumption
Plasma glucose concentrations will be measured from venous blood samples collected at baseline and multiple postprandial time points using a clinical chemistry analyzer (Randox). Unit of Measure: mg/dL
-10 to 240 minutes relative to meal consumption
Change in Plasma Insulin Concentration (µIU/mL)
Tijdsspanne: -10 to 240 minutes relative to meal consumption
Plasma insulin concentrations will be measured from venous blood samples collected at baseline and multiple postprandial time points using a clinical chemistry analyzer (Randox). Unit of Measure: (µIU/mL)
-10 to 240 minutes relative to meal consumption
Change in Plasma Glucagon Concentration (pg/mL)
Tijdsspanne: -10 to 240 minutes relative to meal consumption
Plasma glucagon concentrations will be measured from venous blood samples collected at baseline and multiple postprandial time points using a multiplex immunoassay platform (Luminex). Unit of Measure: pg/mL
-10 to 240 minutes relative to meal consumption
Change in Plasma C-Peptide Concentration (ng/mL)
Tijdsspanne: -10 to 240 minutes relative to meal consumption

Plasma C-peptide concentrations will be measured from venous blood samples collected at baseline and multiple postprandial time points using a multiplex immunoassay platform (Luminex).

Unit of Measure: ng/mL
-10 to 240 minutes relative to meal consumption
Change in Plasma Triglyceride Concentration (mg/dL)
Tijdsspanne: -10 to 240 minutes relative to meal consumption

Plasma triglyceride concentrations will be measured from venous blood samples collected at baseline and multiple postprandial time points using a clinical chemistry analyzer (Randox).

Unit of Measure: mg/dL
-10 to 240 minutes relative to meal consumption
Continuous Glucose Monitoring Metrics During Free-Living Conditions
Tijdsspanne: Approximately 8 days during outpatient monitoring

Interstitial Glucose Concentration during Free-Living Conditions via Continuous Glucose Monitor Description: Interstitial glucose concentration measured continuously during outpatient free-living conditions using the Dexcom G7 continuous glucose monitoring device.

Unit of Measure: mg/dL
Approximately 8 days during outpatient monitoring
Average Daily Step Count (steps/day)
Tijdsspanne: Approximately 8 days during outpatient monitoring.
Average daily step count, reported in steps per day, measured during outpatient free-living conditions using the Fitbit Sense 2 wearable activity tracker.
Approximately 8 days during outpatient monitoring.
Average Daily Active Minutes (minutes/day)
Tijdsspanne: Approximately 8 days during outpatient monitoring.
Average daily active minutes, reported in minutes per day, measured during outpatient free-living conditions using the Fitbit Sense 2 wearable activity tracker.
Approximately 8 days during outpatient monitoring.
Average Daily Sleep Duration (hours/night)
Tijdsspanne: Approximately 8 days during outpatient monitoring.
Average sleep duration, reported in hours per night, measured during outpatient free-living conditions using the Fitbit Sense 2 wearable activity tracker.
Approximately 8 days during outpatient monitoring.
Average Resting Heart Rate (beats/minute)
Tijdsspanne: Approximately 8 days during outpatient monitoring.
Average resting heart rate, reported in beats per minute (bpm), measured during outpatient free-living conditions using the Fitbit Sense 2 wearable activity tracker.
Approximately 8 days during outpatient monitoring.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Dietary Intake Assessment Using ASA24 Dietary Recall
Tijdsspanne: Approximately 8 days during outpatient monitoring
To assess dietary intake and nutritional patterns using self-reported ASA24 dietary recall assessments during the outpatient monitoring period.
Approximately 8 days during outpatient monitoring

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Clinical Nutrition Research Center, Illinois Institute of Technology

Onderzoekers

  • Hoofdonderzoeker: Indika Edirisinghe, Ph.D, Illinois Institute of Technology

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

20 mei 2026

Primaire voltooiing (Geschat)

20 oktober 2026

Studie voltooiing (Geschat)

20 maart 2027

Studieregistratiedata

Eerst ingediend

29 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

12 juni 2026

Eerst geplaatst (Werkelijk)

16 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

16 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

12 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • IRB-2026-33

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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