Digital twin study of blood sugar and hormone responses after a liquid meal

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will collect metabolic and physiologic data from adults with insulin-dependent type 2 diabetes after a standardized liquid meal. Participants wear continuous glucose monitors and activity trackers for about 8 days of free-living monitoring, then undergo an in-clinic liquid meal test with repeated blood sampling over 4 hours to measure glucose, insulin, glucagon, C-peptide, and triglycerides. The goal is to develop mathematical models and digital representations of individual metabolic responses to meals, activity, and diabetes treatments, which could support future personalized diabetes technologies. The study uses screening assessments, outpatient monitoring, and an in-clinic meal challenge performed at the Clinical Nutrition Research Center at IIT.

Why it matters

Who can join: the full rules

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)

Where it's running

• Illinois Institute of Technology
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Indika Edirisinghe, Ph.D — Illinois Institute of Technology
• Study coordinator: Chelsea Preiss, Clinical Research Manager, MS
• Email: cpreiss@illinoistech.edu
• Phone: 312-567-5300

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.