Diabetes Mellitus, Type 2NCT04048642
Effects of a Plant-Based Diet on Insulin Requirements and Obesity Markers in Obese Adults With T2DM
A study testing DASH and Whole-Food, Plant-Based in people with Diabetes Mellitus, Type 2 and Insulin Resistance, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Insulin Resistance, Obesity
- What is being tested?
- DASH and Whole-Food, Plant-Based
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 10 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Show all 9Show fewer
- 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.
Who cannot join
- 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)
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UR Medicine/Highland Hospital Nutrition in Medicine Research Center
Webster, New York, 14580
About this study
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.
Read the 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.
- Being tested
- DASH, Whole-Food, Plant-Based
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance, Obesity, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DASHBehavioural
7 days of a DASH diet
Whole-Food, Plant-BasedBehavioural
7 days of a WFPB diet
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: DASH; Behavioral: Whole-Food, Plant-Based |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total daily insulin requirements
Measured: 7 Days
Secondary outcomes (11)
Changes in glucose excursion curve
Measured: 7 days
Changes in serum leptin
Measured: 7 days
Changes in serum adiponectin
Measured: 7 days
Changes in serum C-peptide levels
Measured: 7 days
Changes in serum insulin levels
Measured: 7 days
Change in lipid panel
Measured: 7 days
Change in hsCRP
Measured: 7 days
Change in IL-6
Measured: 7 days
Change in IL-18
Measured: 7 days
Change in TNF-a
Measured: 7 days
Change in urinary catecholamines
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start1 Dec 2020
- Primary completion10 Feb 2022
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas M Campbell, University of Rochester
- Investigators
- Jonven Attia, MD, Principal investigator, University of RochesterThomas M Campbell, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048642
- Sponsor's protocol ID
- STUDY00003764
- Status last verified
- Mar 2022
- First submitted
- 5 Aug 2019
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38160802
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Plant-Based Diet on Insulin Requirements and Obesity Markers in Obese Adults With T2DM
- ClinicalTrials.gov ID
- NCT04048642
- Acronym / sponsor ID
- STUDY00003764
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 7 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DASH diet; plant-based diet; DASH diet | Experimental | Behavioral: DASH, Behavioral: Whole-Food, Plant-BasedFood 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DASH7 days of a DASH diet | Behavioural | DASH diet; plant-based diet; DASH diet |
| Whole-Food, Plant-Based7 days of a WFPB diet | Behavioural | DASH diet; plant-based diet; DASH diet |
Primary outcome
Change in total daily insulin requirements
Time frame: 7 Days
11 secondary outcomes
Changes in glucose excursion curve
Time frame: 7 days
Changes in serum leptin
Time frame: 7 days
Changes in serum adiponectin
Time frame: 7 days
Changes in serum C-peptide levels
Time frame: 7 days
Changes in serum insulin levels
Time frame: 7 days
Change in lipid panel
Time frame: 7 days
Change in hsCRP
Time frame: 7 days
Change in IL-6
Time frame: 7 days
Change in IL-18
Time frame: 7 days
Change in TNF-a
Time frame: 7 days
Change in urinary catecholamines
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- Derived from this study: PubMed 38160802Campbell 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonven Attia, MD principal investigator
University of Rochester
Thomas M Campbell, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DASH and Whole-Food, Plant-Based in people with Diabetes Mellitus, Type 2 and Insulin Resistance, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total daily insulin requirements (time frame: 7 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04048642, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2022.