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This is a crossover study utilizing a Dietary Approaches to Stop Hypertension (DASH) diet and a whole-food, plant-based diet among subjects with type 2 diabetes who require insulin. Outcomes are short-term changes in insulin requirements and changes in various biomarkers.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DASH diet; plant-based diet; DASH diet | Experimental | Food is provided: 7 days of an ad libitum DASH diet, followed immediately by 7 days of an ad libitum whole food, plant based diet, followed immediately by 7 days of an ad libitum DASH diet again. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DASH | Behavioral | 7 days of a DASH diet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in total daily insulin requirements | 7 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in glucose excursion curve | 7 days | |
| Changes in serum leptin | 7 days | |
| Changes in serum adiponectin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonven Attia, MD | University of Rochester | Principal Investigator |
| Thomas M Campbell, MD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UR Medicine/Highland Hospital Nutrition in Medicine Research Center | Webster | New York | 14580 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38160802 | Derived | Campbell EK, Taillie L, Blanchard LM, Wixom N, Harrington DK, Peterson DR, Wittlin SD, Campbell TM. Post hoc analysis of food costs associated with Dietary Approaches to Stop Hypertension diet, whole food, plant-based diet, and typical baseline diet of individuals with insulin-treated type 2 diabetes mellitus in a nonrandomized crossover trial with meals provided. Am J Clin Nutr. 2024 Mar;119(3):769-778. doi: 10.1016/j.ajcnut.2023.12.023. Epub 2023 Dec 30. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| D009765 | Obesity |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Whole-Food, Plant-Based |
| Behavioral |
7 days of a WFPB diet |
|
| 7 days |
| Changes in serum C-peptide levels | 7 days |
| Changes in serum insulin levels | 7 days |
| Change in lipid panel | 7 days |
| Change in hsCRP | 7 days |
| Change in IL-6 | 7 days |
| Change in IL-18 | 7 days |
| Change in TNF-a | 7 days |
| Change in urinary catecholamines | 7 days |
| D006946 | Hyperinsulinism |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |