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.
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)
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
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.
Cohort
Prospective
Not listed
Change in Plasma Glucose Concentration (mg/dL)
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
Change in Plasma Insulin Concentration (µIU/mL)
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)
Change in Plasma Glucagon Concentration (pg/mL)
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
Change in Plasma C-Peptide Concentration (ng/mL)
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
Dietary Intake Assessment Using ASA24 Dietary Recall
To assess dietary intake and nutritional patterns using self-reported ASA24 dietary recall assessments during the outpatient monitoring period.
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