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Lifestyle Intervention for Patients With Impaired Glucose Regulation

Primary Purpose

Overweight and Obesity

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Low fat diet intensive intervention

Low-Carbon Water Diet Intensive Intervention

About this trial

This is an interventional prevention trial for Overweight and Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Cixi People's HospitalRecruiting
Second Affiliated Hospital of Zhejiang University School of MedicineRecruiting
Jinhua municipal central hospitalRecruiting
Lishui People's HospitalRecruiting
Ningbo Huamei Hospital, University of Chinese Academy of SciencesRecruiting
Shaoxing People's HospitalRecruiting
The first affiliated hospital of Wenzhou medical universityRecruiting
Yuyao People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Arm Label

Group1

Group2

Group3

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Fasting blood glucose

Blood glucose 2 hours after meal

Secondary Outcome Measures

Full Information

NCT ID

NCT04469400

First Posted

June 17, 2020

Last Updated

July 14, 2021

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT04469400

Brief Title

Lifestyle Intervention for Patients With Impaired Glucose Regulation

Official Title

Study on Lifestyle Intervention for Patients With Impaired Glucose Regulation

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Unknown status

Study Start Date

May 1, 2020 (Actual)

Primary Completion Date

February 1, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight and Obesity

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group1

Arm Type

No Intervention

Arm Description

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

Arm Title

Group2

Arm Type

Experimental

Arm Description

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

Arm Title

Group3

Arm Type

Experimental

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Low fat diet intensive intervention

Intervention Description

education and Compound protein solid beverage

Intervention Type

Other

Intervention Name(s)

Low-Carbon Water Diet Intensive Intervention

Intervention Description

education and Nutrition bar

Primary Outcome Measure Information:

Title

Fasting blood glucose

Time Frame

ten weeks

Title

Blood glucose 2 hours after meal

Time Frame

ten weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pianhong zhang

Phone

057187783851

zrlcyyzx@zju.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pianhong Zhang

Organizational Affiliation

Second Affiliated Hospital, School of Medicine, Zhejiang University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cixi People's Hospital

City

Cixi

State/Province

Zhejiang

ZIP/Postal Code

315300

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jianping Shao

Phone

057463911999

Facility Name

Second Affiliated Hospital of Zhejiang University School of Medicine

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310009

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

leilei wang

Phone

057187783851

Facility Name

Jinhua municipal central hospital

City

Jinhua

State/Province

Zhejiang

ZIP/Postal Code

321000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Guifen Hu

Phone

057982338512

Facility Name

Lishui People's Hospital

City

Lishui

State/Province

Zhejiang

ZIP/Postal Code

323020

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shiwei Ye

Phone

05782780222

Facility Name

Ningbo Huamei Hospital, University of Chinese Academy of Sciences

City

Ningbo

State/Province

Zhejiang

ZIP/Postal Code

315010

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Binbin Xu

Phone

05748387099

Facility Name

Shaoxing People's Hospital

City

Shaoxing

State/Province

Zhejiang

ZIP/Postal Code

312000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sue Chen

Phone

057588228888

Facility Name

The first affiliated hospital of Wenzhou medical university

City

Wenzhou

State/Province

Zhejiang

ZIP/Postal Code

325000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Binbin Gu

Phone

057755578033

Facility Name

Yuyao People's Hospital

City

Yuyao

State/Province

Zhejiang

ZIP/Postal Code

315400

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jinjian Pan

Phone

057462629999

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Lifestyle Intervention for Patients With Impaired Glucose Regulation

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