Effects of intermittent protein restriction meal replacement in patients with newly diagnosed type 2 diabetes: a randomized controlled clinical trial study

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200059337

Enrollment

Unknown

Registered

2022-04-28

Start date

2022-04-20

Completion date

Unknown

Last updated

2024-02-26

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

Conditions

Type 2 diabetes

Interventions

IPR Intervention Group:Intermittent protein restriction meal replacement

Blank control group:Lifestyle intervention

Control group:Metformin

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients with type 2 diabetes; 2. Patients aged 18-70 years,male and female can be; 3. At the first visit, HbA1c was 6.5% < HbA1c <=10.0%, and FPG was 7.0mmol/l < FPG <=11.1mmol/l; 4. The patients filled in written informed consent form, basic information questionnaire, and promised to cooperate with the study during the whole experiment period.

Exclusion criteria

Exclusion criteria: 1. Subjects have a major illness or are physically weak; 2. Long-term use of antibiotic or immunosuppressor drugs; 3. Subjects who was diagnosed of gastrointestinal disease; 4. Patients with severe liver damage; 5. Alcoholic Subjects; 6. Participant of other clinical studies.

Design outcomes

Primary

Measure	Time frame
Fasting blood glucose;Blood lipid;Glycated hemoglobin;	—

Secondary

Measure	Time frame
Liver function and kidney function;BMI, Body Mass Index;Waistline;	—

Countries

China

Contacts

Public ContactSong Yongfeng

Shandong Provincial Hospital Affiliated to Shandong First Medical University

syf198506@163.com+86 13280010726

Outcome results

None listed

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