Clinical Trials in the USA / NCT07650682
Recruiting
Observational
Mathematical Modeling of Blood Sugar and Hormone Responses in Insulin-Dependent Type 2 Diabetes
NCT07650682 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Type 2 DiabetesInsulin Dependent Diabetes
Study summary
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.
Eligibility
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)
Primary outcome measure(s)
- Change in Plasma Glucose Concentration (mg/dL) — -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 - Change in Plasma Insulin Concentration (µIU/mL) — -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) - Change in Plasma Glucagon Concentration (pg/mL) — -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 - Change in Plasma C-Peptide Concentration (ng/mL) — -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 - Change in Plasma Triglyceride Concentration (mg/dL) — -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 - Continuous Glucose Monitoring Metrics During Free-Living Conditions — 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 - Average Daily Step Count (steps/day) — 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. - Average Daily Active Minutes (minutes/day) — 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. - Average Daily Sleep Duration (hours/night) — 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. - Average Resting Heart Rate (beats/minute) — 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Illinois Institute of Technology | Chicago | Illinois | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07650682 on ClinicalTrials.gov ↗ ← All trials in the USA