Lifestyle Intervention for Patients With Impaired Glucose Regulation

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04469400
• Collaborator: (none)
• Enrollment: 150
• Locations: 8
• Arms: 3
• Anticipated Duration (Months): 32
• Patients Per Site: 18.8
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity	Dietary Supplement: Low fat diet intensive intervention; Other: Low-Carbon Water Diet Intensive Intervention	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Study on Lifestyle Intervention for Patients With Impaired Glucose Regulation
• Actual Study Start Date: May 1, 2020
• Anticipated Primary Completion Date: Feb 1, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Group1 Researchers conduct health education on patients, including dietary guidance, physical activity guidance, psychological behavior counseling, etc.
Experimental: Group2 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; education and Compound protein solid beverage
Experimental: Group3 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; education and Nutrition bar

Outcome Measures

Primary Outcome Measures

1. Fasting blood glucose [ten weeks]

2. Blood glucose 2 hours after meal [ten weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cixi People's Hospital	Cixi	Zhejiang	China	315300
2	Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang	China	310009
3	Jinhua municipal central hospital	Jinhua	Zhejiang	China	321000
4	Lishui People's Hospital	Lishui	Zhejiang	China	323020
5	Ningbo Huamei Hospital, University of Chinese Academy of Sciences	Ningbo	Zhejiang	China	315010
6	Shaoxing People's Hospital	Shaoxing	Zhejiang	China	312000
7	The first affiliated hospital of Wenzhou medical university	Wenzhou	Zhejiang	China	325000
8	Yuyao People's Hospital	Yuyao	Zhejiang	China	315400

Sponsors and Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

• Principal Investigator: Pianhong Zhang, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
• ClinicalTrials.gov Identifier: NCT04469400
• Other Study ID Numbers: 2019-317
• First Posted: Jul 14, 2020
• Last Update Posted: Jul 16, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Overweight

Study Results

No Results Posted as of Jul 16, 2021