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A Prospective Trial of Low-carbohydrate Diet in the Treatment of Type 2 Diabetes Mellitus

A Prospective Trial of Low-carbohydrate Diet in the Treatment of Type 2 Diabetes Mellitus

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027592
Enrollment
Unknown
Registered
2019-11-20
Start date
2019-12-01
Completion date
Unknown
Last updated
2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Interventions

Group 2:medication
Group 1:diet

Sponsors

Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Voluntary participation and signed informed consent; 2. Aged 18-70 years old; 3. Diagnosis of type 2 diabetes mellitus: according to the "Chinese Type 2 Diabetes Prevention Guide (2017 edition), the diagnostic criteria for diabetes needs to have typical diabetes symptoms (polyuria, polydipsia and unexplained weight loss) with random blood glucose >=11.1mmol/l, or fasting blood glucose (FPG) >=7.0mmol/l, or two-hour plasma glucose >=11.1mmol/l during an oral glucose tolerance test; 4. No typical symptoms of diabetes but meet one of above three criteria, needs to be re-examined; 5. glycated hemoglobin >=7.5% and <=11%; 6. willing to accept SGLT2 inhibitor or low-carbohydrate diet; 7. blood ketone <=0.3mmol/L or negative urine ketone.

Exclusion criteria

Exclusion criteria: 1) Type 1 diabetes mellitus; 2) Have a history of other metabolic-related diseases (such as thyroid dysfunction, Cushing's syndrome, etc.); 3) DKA-related causes such as history of myocardial infarction, chronic pancreatitis, stomach cramps, alcohol abuse (drinking more than 3 standard cups per day; or at least one time drinking more than 5 standard cups per week) and history of DKA; 4) The proportion of carbohydrates in the diet (% of calories) in the past 6 months is 3 times the upper limit of normal, or active liver disease patients; 9) eGFR <60mL/Min/1.73 m2); 10) Patients with urinary tract infection symptoms; 11) Malignant tumors occurred within 2 years; 12) pregnant or lactating women; 13) Those who are participating in or have participated in other clinical research within 4 weeks before the start of the study; 14) The investigator believes that the subject has a disease that affects the outcome assessment or is not suitable for enrollment.

Design outcomes

Primary

MeasureTime frame
HbA1c;

Countries

China

Contacts

Public ContactYIN Jun

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

yinjun@sjtu.edu.cn+86 18930174165

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 11, 2026