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Effects of a Plant-Based Diet on Insulin Requirements and Obesity Markers in Obese Adults With T2DM.

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ClinicalTrials.gov Identifier: NCT04048642
Recruitment Status : Recruiting
First Posted : August 7, 2019
Last Update Posted : January 12, 2021
Sponsor:
Information provided by (Responsible Party):
Thomas M Campbell, University of Rochester

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Insulin Resistance Obesity Nutritional and Metabolic Disease Behavioral: DASH Behavioral: Whole-Food, Plant-Based Not Applicable

Detailed 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 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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: N/A
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of a Plant-Based Diet on Insulin Requirements and Obesity Markers in Obese Adults With T2DM.
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: DASH diet; plant-based diet; DASH diet
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.
Behavioral: DASH
7 days of a DASH diet

Behavioral: Whole-Food, Plant-Based
7 days of a WFPB diet




Primary Outcome Measures :
  1. Change in total daily insulin requirements [ Time Frame: 7 Days ]

Secondary Outcome Measures :
  1. Changes in glucose excursion curve [ Time Frame: 7 days ]
  2. Changes in serum leptin [ Time Frame: 7 days ]
  3. Changes in serum adiponectin [ Time Frame: 7 days ]
  4. Changes in serum C-peptide levels [ Time Frame: 7 days ]
  5. Changes in serum insulin levels [ Time Frame: 7 days ]
  6. Change in lipid panel [ Time Frame: 7 days ]
  7. Change in hsCRP [ Time Frame: 7 days ]
  8. Change in IL-6 [ Time Frame: 7 days ]
  9. Change in IL-18 [ Time Frame: 7 days ]
  10. Change in TNF-a [ Time Frame: 7 days ]
  11. Change in urinary catecholamines [ Time Frame: 7 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults (older than 18 years old) of both genders, of all races and ethnicities.
  • Pre-existing diagnosis of Type 2 diabetes mellitus, as documented in medical records, on basal insulin with or without mealtime bolus insulin and no changes in antihyperglycemic medications in the past 3 months; Patient's on sulfonylureas, glinides and SGLT2 inhibitors will not be included in the study.
  • Adult's on stable dose of GLP-1 analogs for at least 6 months prior to the study enrollment
  • BMI of 27 kg/m2 or greater
  • Most recent HbA1c between 6.5% to 9.5%
  • Fluent in the English language as education about each diet will be in English
  • Willingness and ability to participate in study protocol.
  • Agreeable to give informed consent.

Exclusion Criteria:

  • HbA1c less than 6.5 % or greater than 9.5% within 3 months prior to the study consent.
  • BMI less than 27 kg/m2
  • Diagnosis of T1DM.
  • History of liver cirrhosis.
  • Impaired renal function (GFR < 45 ml/min) within 6 months prior to consent.
  • History of hyperkalemia (potassium > 5.4 meq/L) within 6 months prior to consent.
  • Use of daily aspirin greater than 500 mg or expected to start during the study period
  • Use of daily Vitamin C greater than 1,000 mg or expected to start during the study period
  • Use of antipsychotics or systemic steroids within 3 months prior to consent.
  • Use of weight-lowering pharmacotherapy (phentermine, orlistat, lorcaserin, phentermine/topiramate, bupropion/naloxone) within 3 months prior to consent.
  • The use of insulin secretagogues including sulfonylureas, GLP-1 analogs, and glinides within 3 months prior to consent as this may increase the risk of hypoglycemia and alter assessment of daily insulin requirements during the study.
  • Use of any SGLT2 inhibitors within 3 months prior to consent as this will alter analysis of urinary glucose levels, hence it's mechanism of action as it cause's glucosuria.
  • The use of illicit drugs, defined as active use or use within 3 months prior to consent.
  • Engage in high risk alcohol use (defined as more than 4 drinks on any day or more than 14 per week in men and more than 3 drinks on any day or 7 per week in women).
  • Individuals who are pregnant or intend to become pregnant during the duration of the study.
  • Individuals who are following a vegetarian or vegan diet at the time of consent.
  • Food allergies or intolerances that will interfere with diet adherence.
  • Lack of access to a full size refrigerator (required for storage of 3-4 days of prepared study meals)
  • Active malabsorption disorder, including inflammatory bowel disease, or history of bariatric surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04048642


Contacts
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Contact: Erin Campbell, MD 585-602-0477 erin_campbell@urmc.rochester.edu

Locations
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United States, New York
UR Medicine/Highland Hospital Nutrition in Medicine Research Center Recruiting
Webster, New York, United States, 14580
Contact: Lisa Blanchard    585-602-0476      
Sponsors and Collaborators
University of Rochester
Investigators
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Principal Investigator: Jonven Attia, MD University of Rochester
Principal Investigator: Thomas M Campbell, MD University of Rochester
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Responsible Party: Thomas M Campbell, Assistant Professor of Family Medicine, University of Rochester
ClinicalTrials.gov Identifier: NCT04048642    
Other Study ID Numbers: STUDY00003764
First Posted: August 7, 2019    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Diabetes Mellitus, Type 2
Insulin Resistance
Metabolic Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Diabetes Mellitus
Glucose Metabolism Disorders
Endocrine System Diseases
Hyperinsulinism