Low-Calorie Diets on Type 2 Diabetes Remission

NCT05472272 | Completed

• 1 other identifier: SHMHTCM DM
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Type 2 Diabetes Mellitus; Obesity; Overweight

Keywords

Type 2 diabetes; Diabetes mellitus; Weight loss; Diet; Lifestyle intervention; Obesity

Outcome Measures

Primary Outcomes (2)

• Percent of adherence to the intervention

  Percent of adherence is calculated at the end of the intervention by dividing the number of participants who remain in and adhere to the intervention by the total number of participants who participate in the intervention.

  Baseline to 24 weeks

• Percent of participants achieving significant weight loss and diabetes remission

  Proportion of participants achieving significant weight loss (≥12kg) and diabetes remission, which is defined as having a glycated hemoglobin (HbA1c) level less than 6.5% while receiving no pharmacological therapy for diabetes for at least 3 months, will be estimated at 24 weeks.

  Baseline to 24 weeks

Secondary Outcomes (19)

• Aggregated safety assessment

  Baseline to 24 weeks

• Insulin sensitivity

  Baseline to 24 weeks

• Beta cell function

  Baseline to 24 weeks

• Level of fasting glucose

  Baseline to 24 weeks

• Level of postprandial glucose

  Baseline to 24 weeks

Study Arms (2)

Formula Diet

EXPERIMENTAL

Participants will receive a low-calorie formula diet product.

Other: Formula diet

Food-Based Diet

EXPERIMENTAL

Participants will receive a low-calorie food-based diet created by dietitians.

Other: Food-based diet

Interventions

Formula diet OTHER

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.

Formula Diet

Food-based diet OTHER

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.

Food-Based Diet

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Physician-diagnosed T2DM
• Most recent HbA1c level: 6.5%-12.0%
• Body mass index: 24-45 kg/m2
• Informed consent signed by participants in this study in accordance with requirements of local regulations and the Ethical Review Committee
• No plan to leave Shanghai in 2 years

You may not qualify if:

• Type 1 diabetes
• Current use of insulin and glucagon-like peptide-1 receptor agonists
• Major cardiovascular events (e.g., myocardial infarction, stroke, and heart failure) within the previous 6 months
• Weight loss \>5 kg within the past 6 months
• Diagnosed eating disorders or any dieting behaviors
• Chronic kidney disease stage 3b or higher (estimated glomerular filtration rate \<30 milliliter /min/1.73m2)
• Previously diagnosed psychiatric disorders, e.g., schizophrenia, post-traumatic stress disorder, obsessive-compulsive disorder, uncontrolled depression, uncontrolled epilepsy
• Severe arthritis and gout
• Gallstone disease or known asymptomatic gallstones
• Participation in another clinical research trial
• Being pregnant or have a positive pregnancy test result at screening, or have given birth within the past 90 days, or who are breastfeeding.
• Any known cancers
• Learning difficulties
• Alcoholism
• Pancreatitis

Sponsors & Collaborators

• Shanghai Municipal Hospital of Traditional Chinese Medicine: lead
• Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

Department of Endocrinology, Shanghai Municipal Hospital of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200233, China

Location

Related Publications (2)

• Shi S, Wang S, Wu D, Li K, Yang G, Xu L, Feng N, Du X, Zhong VW. Epigenetic Signatures of Type 2 Diabetes Remission and Substantial Weight Loss: The Role of DNA Methylation in Response to Low-Calorie Diet Intervention. J Am Nutr Assoc. 2025 Nov-Dec;44(8):765-776. doi: 10.1080/27697061.2025.2513378. Epub 2025 Jun 5.

  PMID: 40471649 DERIVED

• Liu Z, Feng N, Wang S, Liu Y, Wang J, Tan Y, Dong Y, Sun Z, Du X, Xu Y, Tao F, Zhong VW. Low-calorie diets and remission of type 2 diabetes in Chinese: phenotypic changes and individual variability. Nutr J. 2025 Mar 14;24(1):42. doi: 10.1186/s12937-025-01101-z.

  PMID: 40087696 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Overweight; Diabetes Mellitus; Weight Loss

Interventions

Food, Formulated

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Foods, Specialized; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Victor Wenze Zhong, Ph.D.

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

• Feng Tao, Ph.D.

  Department of Endocrinology, Shanghai Municipal Hospital of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: This is a non-randomized parallel study without a control arm

Study Record Dates

• First Submitted: July 9, 2022
• First Posted: July 25, 2022
• Study Start: August 3, 2022
• Primary Completion: February 18, 2024
• Study Completion: February 18, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)