Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Diabetes Mellitus - Type 2
  • Insulin Resistance
  • Nutritional and Metabolic Disease
  • Obesity
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Crossover AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

This is a single center, prospective, non-randomized crossover study. The aim of the study is to perform a comprehensive evaluation of factors that may contribute to improvements in glycemic control in obese patients with type 2 diabetes during a plant-based dietary intervention. The primary end poi...

This is a single center, prospective, non-randomized crossover study. The aim of the study is to perform a comprehensive evaluation of factors that may contribute to improvements in glycemic control in obese patients with type 2 diabetes during a plant-based dietary intervention. The primary end point will be the change in total daily insulin requirements during the plant-based dietary intervention period compared against a Dietary Approaches to Stop Hypertension (DASH) diet. Evaluation of insulin requirements will be carried out in three phases of this study: pre-intervention (Phase 1), intervention (Phase 2), and post-intervention (Phase 3). Each phase is 7 days. In addition, investigators plan to evaluate the effects of a plant-based diet on glucose homeostasis by estimating the insulin sensitivity index and beta cell function using weekly sampled oral glucose tolerance tests (oGTT) and will explore if these effects correlate with changes in urinary glucose excretion by using weekly sampled urinary tests. Investigators will also be assessing changes in obesity-related inflammatory biomarkers, stress biomarkers and metabolic markers during the three phases of the study. Lastly, given the current technological advantages in the field of diabetes monitoring, investigators plan to monitor the glycemic excursion curve using a continuous glucose monitor during the complete study.

Tracking Information

NCT #
NCT04048642
Collaborators
Not Provided
Investigators
Principal Investigator: Jonven Attia, MD University of Rochester Principal Investigator: Thomas M Campbell, MD University of Rochester