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Low-Calorie Diets on Type 2 Diabetes Remission

NCT05472272 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2024-05-16

No results posted yet for this study

Summary

The prevalence of type 2 diabetes mellitus (T2DM) has been increasing rapidly in China. China currently has \~130 million diabetes cases, and over 90% are T2DM. T2DM is a leading cause of morbidity and mortality, posing substantial clinical and public health challenges. Reversing T2DM with a significant amount of weight loss via consuming a low-calorie diet is possible, but no studies have been conducted to determine whether low-calorie diets will help achieve significant weight loss and diabetes remission among Chinese patients with T2DM. The investigators design a pilot study to assess the feasibility of a low-calorie diet intervention program on weight loss and diabetes remission in a Chinese population with T2DM.

Conditions

Interventions

OTHER

Formula diet

Participants will receive a low-calorie (815-835 kcal/day; approximately 43% carbohydrate, 29% protein, and 29% fat) formula diet product for 12 weeks, followed by a gradual food reintroduction phase combined with physical activity support for 12 weeks.

OTHER

Food-based diet

Participants will receive a low-calorie (815-835 kcal/day; 45-50% carbohydrate, 20-30% protein, and 20-30% fat) food-based diet created by dietitians for 12 weeks. After 12 weeks, participants will increase energy intake gradually and be encouraged to increase daily physical activity to maintain weight loss for another 12 weeks.

Sponsors & Collaborators

  • Shanghai Jiao Tong University School of Medicine

    collaborator OTHER

  • Shanghai Municipal Hospital of Traditional Chinese Medicine

    lead OTHER

Principal Investigators

  • Victor Wenze Zhong, Ph.D. · Shanghai Jiao Tong University School of Medicine

  • Feng Tao, Ph.D. · Department of Endocrinology, Shanghai Municipal Hospital of Traditional Chinese Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-03
Primary Completion
2024-02-18
Completion
2024-02-18

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05472272 on ClinicalTrials.gov