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

March 9, 2022 updated by: Thomas M Campbell, University of Rochester
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Webster, New York, United States, 14580
        • UR Medicine/Highland Hospital Nutrition in Medicine Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 with or without mealtime bolus insulin with no change to total of basal insulin and nutritional baseline insulin dosing > 10% in the 1 month prior to consent and no changes to non-insulin antihyperglycemic medications in the 3 months prior to consent
  • If on a GLP-1 analog, on a stable dose for at least 3 months prior to the study enrollment
  • If on an SGLT2 inhibitor, on a stable dose for at least 3 months prior to the study enrollment
  • BMI of 27 kg/m2 or greater
  • Most recent HbA1c (within 6 months prior to consent) between 6.5% and 9.5%
  • Fluent in the English language (education about each diet will be in English)
  • Willingness and ability to participate in study protocol.
  • Agreeable to give informed consent.

Exclusion Criteria:

  • Diagnosis of T1DM or type 1.5 diabetes mellitus
  • 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 an insulin pump or expected to start during the study period
  • Use of warfarin (Coumadin)
  • Use of daily aspirin 500 mg or more or expected to start during the study period
  • Use of daily Vitamin C of 1,000 mg or more, unless willing to stop taking 1 week prior to baseline visit and for duration of study
  • Use of antipsychotics or systemic steroids within 3 months prior to consent
  • Use of any of the following weight-lowering pharmacotherapy within 3 months prior to consent: phentermine, orlistat, lorcaserin, phentermine/topiramate, bupropion/naloxone
  • The use of insulin secretagogues including sulfonylureas 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
  • 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 drinks per week in men and more than 3 drinks on any day or 7 drinks per week in women).
  • Individuals who are pregnant or breastfeeding 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 uncontrolled symptomatic inflammatory bowel disease, or bariatric surgery in the past 1 year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in total daily insulin requirements
Time Frame: 7 Days
7 Days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Changes in glucose excursion curve
Time Frame: 7 days
7 days
Changes in serum leptin
Time Frame: 7 days
7 days
Changes in serum adiponectin
Time Frame: 7 days
7 days
Changes in serum C-peptide levels
Time Frame: 7 days
7 days
Changes in serum insulin levels
Time Frame: 7 days
7 days
Change in lipid panel
Time Frame: 7 days
7 days
Change in hsCRP
Time Frame: 7 days
7 days
Change in IL-6
Time Frame: 7 days
7 days
Change in IL-18
Time Frame: 7 days
7 days
Change in TNF-a
Time Frame: 7 days
7 days
Change in urinary catecholamines
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Rochester

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jonven Attia, MD, University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 10, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 10, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 5, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00003764

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on DASH

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings