Effect of Partial Dietary Replacement from Animal to Plant-Based Protein for Type 2 Diabetes Management
140 patients around the world
Available in Brazil
This is a single center, open label, parallel and randomized clinical trial. Subjects
with type 2 diabetes (T2D) and excessive weight will be recruited through advertisement
on the web page of Hospital de Clínicas de Porto Alegre (HCPA), local newspaper,
television and social media, or referred by a doctor or nutritionist, from external to
HCPA services. Patients will be also screened through electronic records of HCPA's
clinics. After screening and selection according to inclusion criteria, participants will
undergo a clinical, laboratory and nutritional evaluation following a standard assessment
protocol. After all baseline assessments, they will be randomly allocated to one of the
following interventions for 24 weeks: (1) Control diet (CDG): hypocaloric diet according
to current guidelines for T2D or (2) Plant-based diet (PBG): hypocaloric diet with
partial replacement of animal protein by plant protein. Both groups will have caloric
targets calculated to achieve a 5% weight loss during the 6 months of study, will have
the same macronutrient distribution on the diet and will receive the same nutritional and
medical support. Telephone calls will be performed monthly for adherence evaluation. At
the end of 12 and 24 weeks of intervention, all patients will be submitted to the same
clinical, laboratory and nutrition exams applied at baseline.
Hospital de Clinicas de Porto Alegre
1Research sites
140Patients around the world
This study is for people with
Diabetes
Diabetes mellitus type 2
Obesity
Requirements for the patient
To 65 Years
All Gender
Medical requirements
Adults (≥18 and ≤65 years old)
Diagnosis of Type 2 Diabetes
Glycated hemoglobin from 7% to 11%
Overweight or obesity (BMI ≥25 kg/m² and <40 kg/m²)
Use of any hypoglycemic and insulin
Stable weight (maximum variation of approximately 5%) for at least 12 weeks before screening
Not having undergone dietary intervention in the last 6 months
Have the ability to understand and be able to adhere to intervention proposals
Able and willing to provide an informed consent form for written and to comply with the requirements of the study protocol
Type 1 diabetes mellitus
Retinopathy with vision deficit that limits the activities proposed in the interventions
Chronic kidney disease with estimated glomerular filtration < 30 mL/min per 1.73m²
Liver failure, chronic viral hepatitis
Grade III or IV heart failure
Active or progressive neurodegenerative disease
Prior stroke that has caused sequelae
Use of medications that affect glucose metabolism (e.g. corticosteroids or immunosuppressants) or cause weight loss
Chronic treatment with oral or parenteral corticosteroids (>7 days consecutive treatment) within 4 weeks prior to screening
Treatment with weight-reducing agents (eg, orlistat, sibutramine, topiramate, bupropion, liraglutide, semaglutide) within the last 12 weeks before screening
Treatment with thyroid hormone that was not maintained at a stable dose in last 12 weeks before screening
History of active substance abuse (including alcohol) within the last year
Thyroid Stimulating Hormone (TSH) outside the normal range
Fasting triglycerides ≥ 600 mg/dL
Tumor diagnosed and/or treated (except basal cell skin cancer, carcinoma in situ of the cervix, or prostate cancer in situ) within the last 5 years
Severe psychiatric illness
Predisposition or diagnosis of eating disorders
Women who are pregnant, intend to become pregnant during the study period, or who are currently breastfeeding
Hyperglycemia characterized by acute symptoms: polyuria, polydipsia and/or weight loss in the last 3 months
Metabolic and acute complications of diabetes such as ketoacidosis or hyperosmolar coma
Potentially unreliable patients and those deemed by the investigator to be unsuitable for the study
Night workers who work after 10pm
Being on a vegetarian, vegan or flexitarian diet at the time of recruitment
Having undergone bariatric surgery
Carriers of the human immunodeficiency virus (HIV)
Any other medical condition/disorder that the investigators consider that are likely to: interfere with the patient's ability to complete the entire study period or participate in study activities
Participants who require any treatment that could affect the interpretation, reliability or safety of data during the study intervention
Sites
Hospital de Clínicas de Porto Alegre - HCPA/UFRGS
Recruiting
Rua Ramiro Barcelos, 2350, Av. Protásio Alves, 211 - Santa Cecília, Porto Alegre - RS, 90035-903