Skip to main content
OpenTrials
Completed

NCT Number: NCT04469400

Lifestyle Intervention for Patients With Impaired Glucose Regulation

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cixi People's Hospital, Cixi, Zhejiang, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low fat diet intensive intervention

Dietary Supplement

education and Compound protein solid beverage

Low-Carbon Water Diet Intensive Intervention

Other

education and Nutrition bar

Primary outcomes

  1. Fasting blood glucose

    Time frame: ten weeks

  2. Blood glucose 2 hours after meal

    Time frame: ten weeks

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

Study on Lifestyle Intervention for Patients With Impaired Glucose Regulation

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 14, 2020
Registry last updated
Jun 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.