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Clinical intervention study on the specific dietary for the patients with type 2 diabetes

The effects of specific dietary on type 2 diabetes

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037450
Enrollment
Unknown
Registered
2020-08-28
Start date
2020-08-28
Completion date
Unknown
Last updated
2020-10-13

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

Conditions

Type 2 diabetes

Interventions

Intervention group:Following the diet regimen, the included patients will take the meal replacement biscuits (Production license number: SC 1243 20205 00293) for 12 continuous weeks, 3 consecutive da
control group:Conventional clinical treatment plan will be adopted without specific diet intervention (the treatment plan of the control group could be adjusted according to the blood glucose, patient

Sponsors

People's Hospital of Deyang City
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. All the included patients should meet the 1999 WHO diagnostic criteria for type 2 diabetes; 2. Poor blood glucose control after diet and exercise therapy and oral antihyperglycemic agents. In addition, 1) the included patients had received diet and exercise therapy previously; 2) they had taken oral antihyperglycemic agents; 3. Hemoglobin a1c (HbA1c) 7.0 to 13% (based on local research centre test); 4. Both of the male and female participated patients should be between 18 and 75 when signing the informed consent; 5. Body Mass Index (BMI): BMI 18 to 35kg/m2 (BMI=weight(kg)/height2/m2); 6. The patients should understand the processes and methods of the study and will to complete the trial strictly in accordance with the clinical trial protocol and sign the informed consent voluntarily.

Exclusion criteria

Exclusion criteria: 1. Women who are pregnant or breast-feeding or have a pregnancy plan; 2. Patients who are likely to be allergic to the ingredients of the specific dietary; 3. Patients are considered inappropriate for this study when they suffer from severe hepatic and renal insufficiency, cardiac insufficiency, cardiovascular and cerebrovascular diseases, mental diseases or other severe diseases, or when they are long-term users of glucocorticoids or other drugs which influence blood sugar; 4. Showing poor compliance during the process, as well as being unable to cooperate with diet control and thus affecting the observation results; 5. Patients had been treated with insulin within three months.

Design outcomes

Primary

MeasureTime frame
height;weight;waistline;Blood routine examination ;Urine routine examination ;Hepatic and renal function;Total cholesterol (TC);Triglycerides (TG);High density lipoprotein cholesterol (HDL-C);Low density lipoprotein cholesterol (LDL-C);Urinary human chorionic gonadotropin (Only the women of childbearing age);C-Peptide;insulin level;CT perfusion image of the pancreas;Vena fasting glucose;hemoglobin A1c;Ultrasonic elastography of pancreas;Visceral fat measurement;Fasting peripheral blood glucose;Blood glucose;

Countries

China

Contacts

Public ContactGang Mai

People's Hospital of Deyang City

yanerw1980@163.com+86 15283831000

Outcome results

None listed

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