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A low-carbohydrate diet improves cardiovascular metabolic risk in patients with type 2 diabetes.

A low-carbohydrate diet improves cardiovascular metabolic risk in patients with type 2 diabetes.

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074530
Enrollment
Unknown
Registered
2023-08-09
Start date
2023-08-10
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

diabetes

Interventions

Experimental group:Intervention of low-carbohydrate diet with carbohydrate content accounting for 25%-30% under the guidance of nutritionists.
Control group:Intervention of low-carbohydrate diet with carbohydrate content accounting for 45%-55% under the guidance of nutritionists.

Sponsors

Sir Run Run Shaw Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1)18-60 years old. 2) According to the diagnostic criteria of China Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020), the patient was diagnosed as diabetes (7.0 mmol/L = FBG < 10 mmol/L, or 11.1 mmol/L=OGTT 2h blood glucose < 15 mmol/L, or 6.5% = HbA1c < 8%, and had no calorie intake for at least 8 hours ), without taking hypoglycemic drugs or insulin. 3)24 kg/m2=BMI<32kg/m2. 4) Be able to use smart phones for operations such as WeChat and taking photos. 5) Being able to take care of oneself in life and having good cognitive ability and memory ability. 6) Participate in this study voluntarily and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Diabetes autoantibodies are positive. 2) Have a history of severe food allergies (such as allergies to wheat bran, eggs, bean products or other food ingredients). History of alcoholism (alcohol intake > 20g/day, about 250ml of yellow rice wine, or 1000ml of beer, or 100ml of white wine). 3) Blood pressure =160/100mmHg, or diagnosed with grade 2 or 3 hypertension (moderate or severe), or systolic blood pressure cannot be controlled below 160mmHg after taking antihypertensive drugs. 4) Triglyceride =5.7mmol/L or LDL-C=4.9mmol/L or currently used lipid-lowering drugs (such as statins, fibrates and cholesterol absorption inhibitors). 5) Severe liver and renal diseases (alanine aminotransferase, aspartate aminotransferase or serum creatinine index exceeds the normal range set by the hospital by 1.5 times). 6) Gastrointestinal diseases that affect food digestion and absorption (such as severe diarrhea, constipation, severe digestive tract inflammation, digestive tract ulcer, acute cholecystitis, etc.). Severe diarrhea refers to watery stool three or more times a day for three days or more, and severe constipation refers to defecation twice a week or less with difficulty in defecation. 7) Severe cardiovascular and cerebrovascular diseases (such as heart failure, myocardial infarction, cerebral infarction, acute myocarditis, severe arrhythmia, patients receiving interventional therapy, etc.). 8) Metal devices such as cardiac stents and pacemakers are built into the body. 9) Cancer or those who have received radiation and chemotherapy within five years. 10) Hyperthyroidism or hypothyroidism. 11) Patients with infectious diseases such as hepatitis B, active tuberculosis and AIDS. 12) Taking drugs that affect weight or body composition one month before the study, including lipid-lowering drugs, oral or injectable contraceptives. 13) Serious illness or hospitalization occurred within one month before the study. 14) Those who have obviously changed their weight within three months before the study. 15) Those who have long-term travel plans within three months after the start of the study. 16) Participated in other clinical studies at present or in the previous three months. 17) Vulnerable groups, including mentally ill people, people with cognitive impairment, critically ill patients, minors, pregnant women and illiterate people.

Design outcomes

Primary

MeasureTime frame
Fasting blood glucose concentration;Postprandial blood glucose concentration;HbA1c;Glycosylated serum albumin;Weight;BMI;Waist circumference;

Secondary

MeasureTime frame
Analysis of lipoprotein subcomponents;Quantification of lipoprotein subgroup;Fasting insulin;Blood fat;Body composition;Blood pressure;

Countries

China

Contacts

Public ContactLiying Chen

Sir Run Run Shaw Hospital

cly0906@163.com+86 135 8870 6741

Outcome results

None listed

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