Diabetes Mellitus
Conditions
Keywords
diabetes remission, weight loss, plant-based, diet, exercise, intensive lifestyle intervention, behavioural intervention, digital program
Brief summary
The goal of this clinical trial is to learn if a plant-based intensive lifestyle intervention can achieve remission of diabetes. It will also learn if a plant-based intensive lifestyle intervention can achieve weight loss ≥15% of initial body weight. The main questions it aims to answer are: * What proportion of participants achieved diabetes remission (normal blood sugar for at least 3 months without medication)? * What proportion of participants achieved ≥15% weight loss from their initial weight? * What is the impact on weight, body composition, blood pressure, blood sugars, cholesterol and inflammation levels? Researchers will compare the plant-based intensive lifestyle intervention to the current standard of care. Participants will be randomly placed into one of two groups: 1. Standard of care, where they will continue their usual diabetes care with their health care providers 2. Plant-based intensive lifestyle intervention, where they will follow a diet and exercise program Participants in the standard of care will: * Continue with their usual diabetes care for 12 months * Attend clinic visits on 5 occasions over the 12 months * Allow study staff to take measurements (e.g. weight, blood pressure) * Provide blood samples * Track their food and exercise and complete questionnaires Participants in the plant-based intensive lifestyle intervention will: * Follow a plant-based low calorie diet for 3 months followed by a calorie-balanced plant-based diet for 9 months * Participate in a 16-week exercise program * Attend clinic visits every 2-4 weeks over the 12 months * Allow study staff to take measurements (e.g. weight, blood pressure) * Provide blood sample * Track their food and exercise and complete questionnaires
Interventions
BEHAVIORALPlant-based intensive lifestyle intervention
The plant-based intensive lifestyle intervention has 2 phases. The first 12-weeks is a weight loss phase consisting of a plant-based, high-plant protein energy restricted total diet replacement (TDR), psyllium-based fibre and complete multivitamin supplements, and vegetable bouillon, with the option of continuing with this phase up to week 20. The second phase is weight-loss maintenance beginning with an 8-week (weeks 12-20) stepped food reintroduction phase with partial meal replacement, progressing towards the 32-week (weeks 20-52) full food introduction phase. These phases focus on introducing a plant-based, high-plant protein, energy balanced, weight loss maintenance diet, which will be supported by a digital program. At weeks 12-28, a 16-week in-person structured exercise training program will be delivered followed by 2-weekly motivational phone calls until the 52-weeks. A 19-session, group-based, structured behavioural support program will be delivered throughout the study.
OTHERStandard of Care
Participants will continue to receive usual diabetes and obesity management as per current Canadian clinical practice guidelines. The management will continue to be delivered to participants through their family doctor, nurse practitioner, or diabetes care team with standard frequency of contact. Participants will attend clinic visits on 5 occasions (weeks 0, 12, 28, 40 and 52) and will receive motivational phone calls between visits to provide reminders regarding follow-up with their diabetes care providers.
Sponsors
Unity Health Toronto
University of Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
The statistician will be masked to the treatments.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age of 18 years; * Equal number of males and females; * Obese (body mass index \[BMI\] and waist circumference using sex and ethnic-specific thresholds for obesity and significant abdominal adiposity); * Diagnosed with type 2 diabetes within the last 6 years; * Treated by non-insulin antihyperglycemic therapy; * Have an HbA1c 6.0-10.0%; * Taking a stable dose of antihypertensive, antihyperglycemic, or antihyperlipidemic medications for ≥3-months, if applicable; * Have a family physician and an Ontario Health Card;
Exclusion criteria
* Type 1 diabetes; * HbA1c \<6.0% or \>10%; * Recent weight loss (≥5 kg) in the last 6 months; * Treated with diet alone; * Treated with insulin; * Treated with GLP-1/GIP/glucagon receptor agonist therapies; * Treated with other anti-obesity drugs; * Eating disorder, substance abuse disorder, serious depression, psychiatric disorder; * Allergy or intolerance to soy; * Allergy or intolerance to peanuts, tree nuts and seeds (all three); * Pregnant or intending pregnancy; * Currently breastfeeding; * Bariatric or surgery in the last 6 months; * Major cardiovascular event in the last 6 months; * Kidney dysfunction; * Unstable or severe heart failure; * Major illness or chronic infection; * Atherosclerotic cardiovascular disease (ASCVD); * Chronic kidney disease (CKD); * Treated for cancer in the last 12 months; * Participating in another trial; * Told by a doctor to refrain from physical activity; * Any condition that would prevent you from following study procedures; * Family physician does not consent to your participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion achieving diabetes remission | From enrollment to the end of treatment at 52 weeks. | Proportion achieving diabetes remission, defined as an HbA1C \<6.5% for ≥3 months free of antihyperglycemic medications at 52 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion achieving ≥10% and ≥5% weight loss from baseline change | From enrollment to the end of treatment at 52 weeks | Proportion achieving ≥10% and ≥5% weight loss from baseline at 52 weeks |
| Changes in measures of body composition | From enrollment to the end of treatment at 52 weeks. | Changes in body weight |
| Proportion experiencing relapse | From enrollment to the end of treatment at 52 weeks. | Proportion experiencing relapse, defined as having achieved remission at any time during the trial but having an HbA1c ≥6.5% at 52 weeks. |
| Changes in functional tests | From enrollment to the end of treatment at 52 weeks. | Changes in sit-stand chair |
| Key secondary: Proportion achieving ≥15% weight loss | From enrollment to the end of treatment at 52 weeks. | Proportion achieving ≥15% weight loss from baseline at 52 weeks. |
| Changes in blood lipids | From enrollment to the end of treatment at 52 weeks. | Changes in LDL-cholesterol, non-HDL cholesterol, HDL-cholesterol, total cholesterol and triglycerides. |
| Changes in blood pressure | From enrollment to the end of treatment at 52 weeks. | Changes in systolic and diastolic blood pressure. |
| Changes in inflammation | From enrollment to the end of treatment at 52 weeks | Changes in c-reactive protein (CRP) |
| Changes in glycemic control | From enrollment to the end of treatment at 52 weeks. | Changes in HbA1c |
Countries
Canada
Contacts
Primary ContactResearch Study Coordinator
Outcome results
None listed