CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 42 enrolled
Drug / intervention
Formula diet +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05472272
NCT05472272N/ACompleted

Effect of Low-Calorie Diets on Remission of Type 2 Diabetes: A Feasibility Study

Shanghai Municipal Hospital of Traditional Chinese Medicine·interventional·Posted Jul 25, 2022·Updated May 16, 2024

In Brief

A clinical study evaluating Formula diet and Food-based diet for Type 2 Diabetes Mellitus and 2 related conditions. Completed, enrolled 42 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina

Timeline

N/ACompletedFinished
2023202420252026
First PostedJul 25, 2022
Enrollment StartAug 3, 2022
Primary CompletionFeb 18, 2024
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 3.9 years ago

Interventions

Formula dietother

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.

Food-based dietother

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.