type II diabetes
Conditions
Interventions
Phase1-Single meal intervention group:Phase 1-Single meal intervention group
Phase-Experimental group:functional foods intervention
Phase 3-Experimental group:functional foods intervention
Phase-Control group:Standard of Diabetes Care Group
Sponsors
The First Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
20 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1: Written informed consent 2: T2DM of duration 0–5 years (diagnosis based on 2 recorded diagnostic-level tests, HbA1c and/or blood glucose) 3: Men and women aged 20–65 years 4: Body Mass Index (BMI) =24 kg/m2,or waist circumference =90 cm for male and =85 cm for female 5: Glycosylated hemoglobin A1c (HbA1c) was 6.5%-10% in participants who had not received antidiabetic drugs for more than 1 year at the time of screening,or using antidiabetic drugs glycosylated hemoglobin A1c (HbA1c) 6.0%-10.0% 6: Fasting C-peptide =1.0 ng/mL
Exclusion criteria
Exclusion criteria: 1: Weight loss of =5 kg within the last 3 months 2: Treatment with anti-obesity drugs within the last 3 months 3: Acute myocardial infarctioncerebrovascular accident and severe heart failure defined as equivalent to the NewYork Heart Association grade 3 (NYHA) 4: Have had bariatric surgery 5: Currently insulin use 6: Diagnosed eating disorder or purging 7: Currently being treated for cancer 8: Treatment with drugs that cause weight gain 9: Blood pressure was still =160/100mmHg for three consecutive different days after using three antihypertensive drugs 10: Recently eGFR <45 ml/min/1.73 m2 11: Moderate to severe liver dysfunction with the Child-Pugh score =7 12: Currently participating in another clinical research trial 13: Pregnant or planning to become pregnant/lactant in the next 6 months 14: Allergic to the functional foods
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of Subjects in Diabetes Remission at 48 weeks;glucose;insulin;Trial completion rate;Incidence of adverse events ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Body Weight;Rate of Subjects in Diabetes Remission at 96 weeks;Change in glucose insulin lipid level;change in HOMA-IR,HOMA-ß;change in ED-5Q-5L;change in DEBQ;change in IWQOL-Lite;change in IPAC;change in DDS;change in SAS;change in SDS;inflammatory cytokines;Liver and pancreas fat; | — |
Countries
China
Contacts
Public ContactJixiong Xu
The First Affiliated Hospital of Nanchang University
Outcome results
None listed