NCT05472272Completed
Low-Calorie Diets on Type 2 Diabetes Remission
Effect of Low-Calorie Diets on Remission of Type 2 Diabetes: A Feasibility Study
Source: ClinicalTrials.gov · Last updated 16 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 42 (actual)
- First submitted
- 9 Jul 2022
- Start date
- 3 Aug 2022
- Primary completion date
- 18 Feb 2024
- Lead sponsor
- Shanghai Municipal Hospital of Traditional Chinese Medicine
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT05472272
What you commit to
- Study type: Interventional
- Participants enrolled: 42
- From 3 Aug 2022 to the primary completion date, 18 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Major cardiovascular events (e.g., myocardial infarction, stroke, and heart failure) within the previous 6 months
- Previously diagnosed psychiatric disorders, e.g., schizophrenia, post-traumatic stress disorder, obsessive-compulsive disorder, uncontrolled depression, uncontrolled epilepsy
Other illness
- Type 1 diabetes
- Diagnosed eating disorders or any dieting behaviors
- Chronic kidney disease stage 3b or higher (estimated glomerular filtration rate \<30 milliliter /min/1.73m2)
- Gallstone disease or known asymptomatic gallstones
- Any known cancers
Other
- Current use of insulin and glucagon-like peptide-1 receptor agonists
- Weight loss \>5 kg within the past 6 months
- Severe arthritis and gout
- 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.
- Learning difficulties
- Alcoholism
- Pancreatitis
Who the study is looking for
- 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
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Endocrinology, Shanghai Municipal Hospital of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.