Type 2 Diabetes Mellitus (T2DM) Type 2 Diabetes Mellitus (T2DM) carbohydrates tapioca starch
Conditions
Interventions
medical food products containing carbohydrates from tapioca starch, used as meal replacement, 3 meals/day, 4 days/week,Lifestyle modification only (standard of care)
Experimental Dietary Supplement,No Intervention No treatment
medical food products containing carbohydrates from tapioca starch,lifestyle only
Sponsors
Agricultural Research Development Agency (ARDA)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Age between 18-60 years 2.stable body weight or change of no more than 5% 3.waist circumference exceeding than standard threshold 4.diagnosed with DM type 2 and recieving either: lifestyle modification and lifestyle modification in combination with oral antidiabetic medications (metformin, pioglithazone, sulfonylurea or SGLT2 inhibitors) aith HbA1C >=9% 5. Availability of health check up result within the past 1 year 6.no changes in medication regimen eithin the past 3 months prior to enrollment 7.willing to participate in the study
Exclusion criteria
Exclusion criteria: 1.History of severe hypoglycemia with neuroglycopenic symptoms within the past 3 months 2.History of severe diabetic complications such as limb amputation or diabetic coma 3.History of significant GI dysfunction such as short bowel syndrome 4.sinificant impairment of cardiac, pulmonary or circulatary function such as ischemic heart disease, cerebrovascular diseaese, or history of heart failure within 6 weeks prior to enrollment 6.Renal function with GFR < 60 7. Signiuficant psychiatric disorder s such as schizoprenia, severe depression or dementia that impair ability to provide inform consent or history of alcohol or substance abuse 8.Symptomatic thyroid dysfunctioneg hypothyroidism or hyperthyroidism 9.HIstory of cancer or detection of malignant cells withhin the past 5 years 10.Pregnant or breastfeeding women or those unwilling to use contraception 11.current uses of herbal products, dietary supplements or systemic corticosteroids except topical steroids for at least 7 consecutive days 12. known allergy to any ingredient or component of the medical nutrition formula used in the study 13.presence of a pacemaker, defibrillator, or any implanted metal device that contraindicates measurement using bioelectrical impedance analysis (BIA)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1C Baseline and day91 blood test | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting plasma glucose Baseline, day30, and day91 Blood test,Lipid profile Baseline and day91 Blood test,Body weight Baseline, day14, day30, day60, day91 Scale,Waist circumference Baseline, day14, day30, day60, day91 Measuring tape | — |
Countries
Thailand
Contacts
Public ContactPornpoj Pramyothin
Mahidol University
Outcome results
None listed