Overweight, Obesity, Type 2 diabetes, Metabolic syndrome, Abdominal obesity Overweight, Obesity, Type 2 diabetes, Metabolic syndrome, Abdominal obesity
Conditions
Interventions
The meal replacement group will receive lifestyle intervention plus and a diabetic specific formula to replace two meals per day for 12 weeks plus one regular meal guided by the plate model and food
Meal replacement group,Lifestyle intervention group
Sponsors
Program Management Unit for Competitiveness Enhancement (PMU-C).
BANPONG NOVITAT COMPANY LIMITED
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.BMI of at least 23 kg per square meter 2.Diagnosed with type 2 diabetes mellitus with HbA1c less than 12.5 percent 3.Stable body weight during the past 3 months 4.Managed with diet or antidiabetic agents only 5.No change in diabetes medication within the past 3 months 6.Willingness to participate and sign written informed consent
Exclusion criteria
Exclusion criteria: 1.Currently on GLP 1 receptor agnists 2.Chronic kidney disease , GFR less than 30 mL per min per 1.73 square meter 3.Severe liver disease or history of alcohol/substance abuse 4.Known allergy to milk protein or any DSF ingredients 5.Pregnancy or lactation 6.Uncontrolled psychiatric illness such as uncontrolled depression and schizophrenia 7.Anemia from hemolysis, iron or vitamin B12 deficiency based on baseline CBC 8.Use of medications or supplements such as vitamin C, E, opioids, interferon alpha, or ribavirin 9.Blood transfusion within the past 3 months 10.Asplenia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glucose control 2, 4 and 12 weeks A1C Change,Glucose Control 2, 4 and 12 weeks FPG change | — |
Secondary
| Measure | Time frame |
|---|---|
| Weight 2, 4 and 12 weeks weight and body mass index change,Body composition 2, 4 and 12 weeks Body composition change,Blood pressure 2, 4 and 12 weeks Blood pressure change,Lipid 2, 4 and 12 weeks Lipid profile change,Insulin resistance 2, 4 and 12 weeks HOMA-IR change,Muscle strenght 2, 4 and 12 weeks Hand grip strength change,Physical performance 2, 4 and 12 weeks 5 time chair stand,Improvement in comorbidities 8, 12 weeks Change in antihypertensive medication and lipid- lowering medication use, and shift in glycaemic status.,Diabetes remission or improvement 8, 12 weeks Changes in number of antidiabetes medications , normalization of FPG and A1C | — |
Countries
Thailand
Contacts
Public ContactPrapimporn Shantavasinkul
Ramathibodi Hospital
Outcome results
None listed