Lifestyle Intervention for Patients With Impaired Glucose Regulation

NCT04469400 | Completed

• 1 other identifier: 2019-317
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 8

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.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (2)

• Fasting blood glucose

  ten weeks

• Blood glucose 2 hours after meal

  ten weeks

Study Arms (3)

Group1

NO INTERVENTION

Researchers conduct health education on patients, including dietary guidance, physical activity guidance, psychological behavior counseling, etc.

Group2

EXPERIMENTAL

In addition to education, the subjects will consume 2 composite protein solid drinks per day, in conjunction with the three-meal diet to increase satiety and intake of sufficient nutrients

Dietary Supplement: Low fat diet intensive intervention

Group3

EXPERIMENTAL

In addition to education, the subjects will consume 2 nutrition bars daily to replace the staple food of daily lunch and dinner to help reduce carbohydrate intake and intake of sufficient nutrients

Other: Low-Carbon Water Diet Intensive Intervention

Interventions

Low fat diet intensive intervention DIETARY_SUPPLEMENT

education and Compound protein solid beverage

Group2

Low-Carbon Water Diet Intensive Intervention OTHER

education and Nutrition bar

Group3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• kg/m2 ≤ BMI ≤ 35 kg/m2
• Those who are willing to accept assessment and sign informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (8)

Cixi People's Hospital

Cixi, Zhejiang, 315300, China

Location

Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

Jinhua municipal central hospital

Jinhua, Zhejiang, 321000, China

Location

Lishui People's Hospital

Lishui, Zhejiang, 323020, China

Location

Ningbo Huamei Hospital, University of Chinese Academy of Sciences

Ningbo, Zhejiang, 315010, China

Location

Shaoxing People's Hospital

Shaoxing, Zhejiang, 312000, China

Location

The first affiliated hospital of Wenzhou medical university

Wenzhou, Zhejiang, 325000, China

Location

Yuyao People's Hospital

Yuyao, Zhejiang, 315400, China

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pianhong Zhang

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: July 14, 2020
• Study Start: May 1, 2020
• Primary Completion: February 1, 2022
• Study Completion: December 31, 2022
• Last Updated: June 24, 2024

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)