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Effect of Low-Calorie Diet and Ketogenic Diet Intervention on Reversal of T2DM

Effect of Low-Calorie Diet and Ketogenic Diet Intervention on Reversal of T2DM

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102119
Enrollment
Unknown
Registered
2025-05-08
Start date
2024-08-08
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

T2DM

Interventions

Control Group:Diet for diabetes, maintain the existing hypoglycemic program
KD group:ketogenic diet intervention (diets with low proportion of carbohydrate and high proportion of fat), maintain the existing hypoglycemic program ?
LCD group:Low carbon dietary intervention(the intake of carbohydrates is less than 130 g/d or less than 520 kcal / d, on the basis of protein, vitamin, minerals

Sponsors

Guangdong Second Provincial General Hospital (Guangdong Provincial Emergency Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. BMI (kg/m^2) > 25, age > 18 years and < 65 years; 2. Patients with T2DM or impaired glucose tolerance or fasting blood glucose who have normal kidney and liver function, are overweight/obese, and exclude patients with concomitant conditions such as hyperuricemia and hypertension; 3. Voluntarily participate in and cooperate with the research and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Pregnant women or women who plan to become pregnant during the study period, women who are currently breastfeeding, or women who have the ability to conceive without using efficient and medically recognized contraceptive methods; 2. Gastrointestinal diseases or surgical history, including intestinal obstruction, intestinal ulcer, weight loss surgery or strap surgery, gastrointestinal anastomosis, and intestinal resection; 3. Poor control of severe hypertension, i.e. systolic blood pressure >= 180mmHg and/or diastolic blood pressure >= 110mmHg; Patients with systolic blood pressure<95mmHg; 4. Currently identified by researchers as unstable or severe cardiovascular, kidney, liver, hematological, oncological, endocrine, psychiatric, or rheumatic diseases; 5. History of drug abuse, alcoholism, or drug use within the past 6 months; 6. Subjects who are unable to comply with the protocol at the discretion of the researchers, and patients with serious physiological or psychological disorders that may affect effectiveness or safety; 7. Engage in heavy physical labor; 8. Unable to cooperate and complete the entire intervention or observation due to various other factors.

Design outcomes

Primary

MeasureTime frame
HbA1c%;Glu;BMI;

Secondary

MeasureTime frame
Analysis of metabolomics;Analysis of Single cell transcriptome;Patient self-management ability;Renal function;

Countries

China

Contacts

Public ContactZeng Keijing

Guangdong Second Provincial General Hospital (Guangdong Provincial Emergency Hospital)

zengkj3@mail3.sysu.edu.cn+86 18816794108

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026