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Status:

UNKNOWN

Impact of Exercise Intervention on the Phenome

Lead Sponsor:

Shanghai Jiao Tong University School of Medicine

Conditions:

Overweight and Obesity

Physical Activity

Eligibility:

All Genders

18-65 years

Phase:

NA

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 peopl...

Detailed Description

The trial will recruit 270 patients from 2 hospitals within the China Diabetes Clinical Research Network. Eligible criteria include men and women aged 18-65 years; with normal glucose metabolism or pr...

Eligibility Criteria

Inclusion

  • 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
  • 2h-PG\<7.8mmol/L and
  • HbA1c\<5.7%;
  • Pre-diabetes:
  • 6mmol/L ≤ FBG ≤ 6.9mmol/L and/or
  • 8mmol/L ≤ 2h-PG ≤ 11.0mmol/L and/or
  • 7% ≤ HbA1c ≤ 6.4%;
  • Newly diagnosed diabetes:
  • o Duration of type 2 diabetes is less than 5 years;
  • No insulin treatment;
  • 23 Kg/m2 ≤ Body mass index (BMI) \<40 Kg/m2;

Exclusion

  • Eligibility Minimum Age: 18 Years Maximum Age: 65 Years Sex: All Gender Based: No Accepts Healthy Volunteers: No
  • Criteria: Inclusion Criteria:
  • 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
  • 2h-PG\<7.8mmol/L and
  • HbA1c\<5.7%;
  • Pre-diabetes:
  • 6mmol/L ≤ FBG ≤ 6.9mmol/L and/or
  • 8mmol/L ≤ 2h-PG ≤ 11.0mmol/L and/or
  • 7% ≤ HbA1c ≤ 6.4%;
  • Newly diagnosed diabetes:
  • o Duration of type 2 diabetes is less than 5 years;
  • No insulin treatment;
  • 23 Kg/m2 ≤ Body mass index (BMI) \<40 Kg/m2;

Key Trial Info

Start Date :

June 15 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 30 2023

Estimated Enrollment :

270 Patients enrolled

Trial Details

Trial ID

NCT04919603

Start Date

June 15 2021

End Date

May 30 2023

Last Update

June 9 2021

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Shanghai Institute of Endocrine and Metabolic Diseases

Shanghai, Shanghai Municipality, China, 200025

2

The Third People's Hospital of Datong City

Datong, Shanxi, China