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A randomized control trial for a moderate carbohydrate diet compared to a low carbohydrate diet in overweight or obese individuals with type 2 diabetes mellitus or prediabetes

A randomized control trial for a moderate carbohydrate diet compared to a low carbohydrate diet in overweight or obese individuals with type 2 diabetes mellitus or prediabetes

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022930
Enrollment
Unknown
Registered
2019-05-04
Start date
2019-05-05
Completion date
Unknown
Last updated
2019-05-05

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

Conditions

overweight

Interventions

the Calorie-restricted low-carbohydrate diet group:participants in this group were asked to follow a very low carbohydrate, high protein, calorie-restricted diet whose goal is to induce a low level of

Sponsors

The First Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Diabetes: fasting blood glucose = 7.0mmol / L or 2 hours after sugar load = 11.1mmol/L. Pre-diabetes: fasting blood glucose <7.0mmol/L, 2 hours after glucose load, blood glucose = 7.8mmol/L but <11.1mmol/L; (2) Body mass index BMI = 26.0 kg / m2; or waist circumference = 90cm (men), waist circumference = 85cm (women); (3) Subjects who are suitable and able to adhere to therapeutic lifestyle interventions without contraindications; (4) Subjects who are volunteered to participate in the study, and who will be able to provide informed consent.

Exclusion criteria

Exclusion criteria: (1) Contraindications for therapeutic lifestyle intervention: type 1 diabetes, severe type 2 diabetes, diabetic nephropathy, severe valvular heart disease, heart failure, aortic aneurysm and dissection aneurysm; infection, deep vein thrombosis, mental illness, central nervous system Disease, hemorrhagic disease, chronic kidney disease including severe kidney stones, gout, renal insufficiency, severe digestive system diseases, anemia, cirrhosis, malignant tumors, gastrointestinal diseases or surgical history, including intestinal obstruction, intestinal ulcer, weight loss surgery or band surgery, gastrointestinal anastomosis, bowel resection, etc.; (2) Cushing/Cushing's syndrome and other obesity caused by diseases of the endocrine system; (3) Progressive malignant tumor or severe disease with poor prognosis.

Design outcomes

Primary

MeasureTime frame
Average change rate of body weight from Baseline to 4 and 8 weeks.;Average change rate of total body fat mass from Baseline to 4 and 8 weeks.;Average change rate of total lean mass from Baseline to 4 and 8 weeks.;Average change rate of fasting blood glucose from Baseline to 4 and 8 weeks.;Average change rate of glycated hemoglobin from Baseline to 4 and 8 weeks.;

Secondary

MeasureTime frame
Average change rate of glucose profile from Baseline to 4 and 8 weeks, including oral glucose tolerance test (0,30 min, 2h), serum insulin level, homeostasis model insulin resistance index.;Average change rate of lipid profile from Baseline to 4 and 8 weeks, including total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglyceride (TG);Average change rate of blood pressure from Baseline to 4 and 8 weeks, including systolic blood pressure (SBP), diastolic blood pressure (DBP).;Average change rate of liver enzymes from Baseline to 4 and 8 weeks, including aspartate aminotransferase (AST), alanine aminotransferase (ALT);Average change rate of renal function from Baseline to 4 and 8 weeks, including urea nitrogen (UN), uric acid (UA), creatinine (Cr), estimated glomerular filtration rate (eGFR), ketonuria, microalbuminuria;Average change rate of other hematological indicators from Baseline to 4 and 8 weeks, including IGF-1, IL-6, TNF-a, adiponectin, leptin, hypersensitive c-reactive protein, homocysteine.;

Countries

China

Contacts

Public ContactYan bin Ye; Yan Zhang

The First Affiliated Hospital of Sun Yat-sen University

yanbinye72@163.com+86 15813315086

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026