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Lifestyle Intervention for Patients With Impaired Glucose Regulation

Study on Lifestyle Intervention for Patients With Impaired Glucose Regulation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04469400
Enrollment
116
Registered
2020-07-14
Start date
2020-05-01
Completion date
2022-12-31
Last updated
2024-06-24

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

Conditions

Overweight and Obesity

Brief summary

Impaired glucose regulation (IGR) is closely related to overweight/obesity. By studying different dietary patterns (energy-limited diet vs. low-carbohydrate diet) and intensive lifestyle interventions combined with blood glucose monitoring, glucose regulation of overweight/obesity is affected. To improve the blood glucose and related metabolic indexes of patients with impaired (IGR), establish 1-2 clinical intervention programs for impaired glucose regulation.

Interventions

DIETARY_SUPPLEMENTLow fat diet intensive intervention

education and Compound protein solid beverage

OTHERLow-Carbon Water Diet Intensive Intervention

education and Nutrition bar

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Age 18-65 years old ② Fasting blood glucose is between 5.6-6.9 mmol/L (100-125mg/dL) or oral glucose tolerance test (OGTT) 2h plasma glucose (2h-PG) is 7.8-11.1 mmol/L (140-200 mg/dL) * 24 kg/m2 ≤ BMI ≤ 35 kg/m2 * Those who are willing to accept assessment and sign informed consent.

Exclusion criteria

* Patients diagnosed with diabetes or undergoing diabetes treatment; * Receiving drugs or surgery for weight loss at present or in the past 3 months; * Receiving corticosteroid or thyroid hormone treatment; * Secondary obesity caused by endocrine, genetic, metabolic and central nervous system diseases; * Patients with abnormal liver function (alanine aminotransferase or/and aspartate aminotransferase exceeding the upper limit of normal value 3 times); patients with abnormal renal function (serum creatinine exceeding the upper limit of normal value); suffering from kidney disease and other diseases that need to control protein intake; * Diseases affecting the digestion and absorption of food (such as chronic diarrhea, constipation, severe gastrointestinal inflammation, active gastrointestinal ulcer, gastrointestinal resection, cholecystitis/cholecystectomy, etc.); ⑦ Suffering from cardiovascular and cerebrovascular diseases, grade 3 hypertension, chronic hepatitis, malignant tumors, anemia, mental illness and memory disorders, epilepsy and other diseases; ⑧ Suffering from infectious diseases such as active tuberculosis and AIDS; ⑨ During pregnancy or lactation; ⑩Patients with physical disabilities and clinicians think it is not suitable to participate in the study (for example, have a serious disease not included in the discharge criteria) or are unwilling to participate in this study.

Design outcomes

Primary

MeasureTime frame
Fasting blood glucoseten weeks
Blood glucose 2 hours after mealten weeks

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026