Impact of Exercise Intervention on the Phenome

NCT04919603 | Unknown DMC

• 1 other identifier: 1.0/2020-07-29
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 2

Brief Summary

It is an open-label, parallel-group, randomized controlled clinical trial, which is designed to enroll people with different glucose metabolism status who are also overweight or obese, including people with normal glucose metabolism, pre-diabetes patients and newly diagnosed type 2 diabetes patients. The patients are randomized to an enhanced physical activity intervention (high-intensity interval training exercise prescription combined with resistance training) or standard education group (diabetes health education only, including lifestyle education and guidance) for 12 weeks. This trial intends to compare the influence of enhanced physical activity treatment with that of a standard education on liver steatosis, serum glucose and lipids level, insulin sensitivity, cardiovascular metabolic parameters, metabolic molecules, and gut microbiota profile et al.

Conditions

Overweight and Obesity; Physical Activity

Outcome Measures

Primary Outcomes (1)

• Change in liver steatosis quantified by MRI-PDFF (percentage)

  12 weeks

Secondary Outcomes (30)

• Change in liver steatosis quantified by MRI-PDFF (percentage)

  1 year

• Change in the level of fasting blood glucose (mmol/l)

  12 weeks and 1 year

• Change in the level of plasma glucose of 2 hours post glucose-load (mmol/l)

  12 weeks and 1 year

• Change in the level of HbA1c (percentage)

  12 weeks and 1 year

• Change in body mass index (BMI)

  12 weeks and 1 year

Study Arms (2)

Enhanced physical activity group

EXPERIMENTAL

the participants will take high-intensity exercise in accordance with High Intensity Interval Training (HIIT) prescriptions, with maximum heart rate and relative maximal oxygen uptake monitored. They will take both aerobic and resistance training exercise consecutively, and total training time will be expected to reach at least 150 minutes per week.

Behavioral: Enhanced physical activity intervention

Standard education group

EXPERIMENTAL

the participants will receive no extra intervention but diabetes health education, which will be carried out in large classrooms, in groups, and over the telephone. The education is mainly consisted of instructions on diabetes prevention according to \< Guidelines for prevention and treatment of type 2 diabetes in China (2017 edition)telephone. The education is mainly consisted of instructions on diabetes prevention according to \< Guidelines for prevention and treatment of type 2 diabetes in China (2017 edition)\>.

Behavioral: Standard education

Interventions

Enhanced physical activity intervention BEHAVIORAL

the participants will take high-intensity exercise in accordance with High Intensity Interval Training (HIIT) prescriptions, with maximum heart rate and relative maximal oxygen uptake monitored. They will take both aerobic and resistance training exercise consecutively, and total training time will be expected to reach at least 150 minutes per week.

Enhanced physical activity group

Standard education BEHAVIORAL

the participants will receive no extra intervention but diabetes health education, which will be carried out in large classrooms, in groups, and over the telephone. The education is mainly consisted of instructions on diabetes prevention according to \< Guidelines for prevention and treatment of type 2 diabetes in China (2017 edition)

Standard education group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 18-65 years;
• Normal glucose metabolism or pre-diabetes or newly diagnosed type 2 diabetes
• Normal glucose metabolism:
• FBG\<5.6mmol/L and
• h-PG\<7.8mmol/L and
• HbA1c\<5.7%;
• Pre-diabetes:
• mmol/L ≤ FBG ≤ 6.9mmol/L and/or
• mmol/L ≤ 2h-PG ≤ 11.0mmol/L and/or
• % ≤ HbA1c ≤ 6.4%;
• Newly diagnosed diabetes:
• o Duration of type 2 diabetes is less than 5 years;
• No insulin treatment;
• Kg/m2 ≤ Body mass index (BMI) \<40 Kg/m2;

You may not qualify if:

• Eligibility Minimum Age: 18 Years Maximum Age: 65 Years Sex: All Gender Based: No Accepts Healthy Volunteers: No
• Men and women aged 18-65 years;
• Normal glucose metabolism or pre-diabetes or newly diagnosed type 2 diabetes
• Normal glucose metabolism:
• FBG\<5.6mmol/L and
• h-PG\<7.8mmol/L and
• HbA1c\<5.7%;
• Pre-diabetes:
• mmol/L ≤ FBG ≤ 6.9mmol/L and/or
• mmol/L ≤ 2h-PG ≤ 11.0mmol/L and/or
• % ≤ HbA1c ≤ 6.4%;
• Newly diagnosed diabetes:
• o Duration of type 2 diabetes is less than 5 years;
• No insulin treatment;
• Kg/m2 ≤ Body mass index (BMI) \<40 Kg/m2;

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (2)

Shanghai Institute of Endocrine and Metabolic Diseases

Shanghai, Shanghai Municipality, 200025, China

NOT YET RECRUITING

The Third People's Hospital of Datong City

Datong, Shanxi, China

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity; Motor Activity

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Yufang Bi, MD, PhD

CONTACT

+862164370045; byf10784@rjh.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: June 9, 2021
• Study Start: June 15, 2021
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2023
• Last Updated: June 9, 2021

Record last verified: 2021-06

Locations

CN (2)