NCT04928872

Macronutrient Distribution and Plasma Metabolites to Model Meals Composition

The Relation Between the Meal Macronutrient Distribution and Plasma Metabolites to Model the Composition of Meals of Patients With Diabetes II and Cardiovascular Disease.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 23 (actual)
• Sponsor: Texas A&M University · Academic / Other
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Accepted

Summary

Continuous glucose monitors (CGMs) measure plasma glucose concentration continually and thus they are a key tool in the management of diabetes, including type 2 diabetes (T2D). A key factor in diabetes management is a reduction of dietary carbohydrates (CHO) and/or exchanging high glycemic index (GI) CHO with low GI CHO. However, the protein and fat content of the meal can have a significant impact on the glucose readings obtained from a CGM as there is no enough data available on their sensitivity during meals.

Detailed description

The study involves 1 screening visit of approximately 1 hour and 9 study days of approximately 8 hours. Subjects will be asked to arrive in the fasted state on all study days. Fasting prior to screening is not required. On the screening day, body weight, height, and body composition by Dual-energy X-ray absorptiometry (DXA) will be measured. In addition, habitual dietary intake, physical activity level (PASE), and quality of life (SGRQ-C) will be assessed. To test the relation between plasma amino acid, triglycerides, and glucose concentration measured by standard methods (such as finger stick) and continuous wearable devices, a premarket FDA-approved continuous glucose monitor (CGM) from Abbott (FreeStyle Libre Pro) that monitors glucose concentrations every 15 min is used. The single-use sensors are placed on the upper arm and contain a very tiny 5 mm filament (\<0.4 mm diameter) that is introduced into the skin when the sensor is placed. On the first study day, the CGM will be placed to monitor glucose concentrations until the last study day. At least every 14 days, sensors will be replaced by new ones. On each study day, body weight and height will be measured and the glucose concentration data will be downloaded from the sensor onto the reader device. A catheter will be inserted in a peripheral vein of the lower arm or hand to enable blood sampling. The arm will be put in a hot box to allow collecting arterialized venous blood samples. After taking a baseline blood sample, the predefined meal will be consumed within 10 min. Small arterialized venous blood samples (5 ml) will subsequently be drawn at times: 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420, and 480 minutes (13 blood samples, total blood approx 65 ml). Samples will be collected in predefined tubes, plasma/serum separated, aliquoted, and stored at -80 deg. Celsius for later assays and/or send to a local accredited laboratory for the concentrations of amino acids and other parameters (including fatty acids, glucose, insulin).

Conditions

• Glucose Metabolism

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Predefined meal	Nine predefined meals are administered in a randomized fashion, one meal per one study day, 2-3 study days per week. Meals have a form of drinks with different compositions of protein, carbohydrates and fat in relation to the US diet

Timeline

• Start date: 2018-06-20
• Primary completion: 2020-01-14
• Completion: 2020-01-14
• First posted: 2021-06-16
• Last updated: 2022-02-21

Locations

1 site across 1 country: United States