Clinical trial NCT05472272: Low-Calorie Diets on Type 2 Diabetes Remission
Official title: Effect of Low-Calorie Diets on Remission of Type 2 Diabetes: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Obesity
Overweight
Keywords: Type 2 diabetes
Diabetes mellitus
Weight loss
Diet
Lifestyle intervention
Obesity
Lead sponsor: Shanghai Municipal Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Jiao Tong University School of Medicine
First posted: 2022-07-25
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a non-randomized parallel study without a control arm
Primary purpose: TREATMENT

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.

Detailed description: Consistent evidence has shown that overweight and obesity are the leading cause of T2DM, which exacerbates the development of insulin resistance and disease progression. For overweight and obese patients with T2DM, there is a strong consensus that sustained and moderate weight loss can effectively improve glycemic control and blood pressure as well as reduce the need for glucose-lowering medications and improve quality of life.

Short-term dietary interventions using structured low-calorie diets (800-1,000 kcal/day) have shown to be an effective approach for losing weight and promoting sustained diabetes remission in T2DM patients who are overweight or obese. The United Kingdom DiRECT research team designed a structured, intensive intervention program of 12-20 weeks to achieve substantial weight loss and T2DM remission through energy restriction. Researchers recorded ≥15 kg of weight loss in 24% of the participants who underwent a low-calorie formula diet intervention (total diet replacement with 825-853 kcal/day formula low-energy diet meal replacement products). Among these participants, the diabetes remission rate reached 90%.

This non-randomized dietary intervention study comprises 2 study arms: a formula diet (815-835 kcal/day) and a food-based diet (815-835 kcal/day). Participants will be on either of the two low-calorie diets for 12 weeks to achieve at least 12 kg of weight loss (intensive weight loss phase). Participants may extend the weight loss phase if desired. After 12 weeks, participants in the formula diet group are allowed to consume actual meals gradually, and participants in both groups will increase their energy consumption gradually over the next 12 weeks (weight loss achievement and maintenance phase). Physical activity is recommended during the second phase for maintaining weight loss. This study is designed to assess feasibility of the low-calorie diet intervention, in preparation for a full-scale randomized control study. This pilot study also plans to explore potential mechanisms of the intervention for weight loss and diabetes remission.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percent of adherence to the intervention
timeFrame: Baseline to 24 weeks
measure: Percent of participants achieving significant weight loss and diabetes remission
timeFrame: Baseline to 24 weeks
Secondary outcomes:
measure: Aggregated safety assessment
timeFrame: Baseline to 24 weeks
measure: Insulin sensitivity
timeFrame: Baseline to 24 weeks
measure: Beta cell function
timeFrame: Baseline to 24 weeks
measure: Level of fasting glucose
timeFrame: Baseline to 24 weeks
measure: Level of postprandial glucose
timeFrame: Baseline to 24 weeks
measure: Level of HbA1c
timeFrame: Baseline to 24 weeks
measure: Glucose homeostasis
timeFrame: Baseline to 24 weeks
measure: Body fat composition and fat distribution
timeFrame: Baseline to 24 weeks
measure: Gut microbiota
timeFrame: Baseline to 24 weeks
measure: Traditional Chinese Medicine(TCM) tongue diagnosis estimated by tongue-face diagnosis instrument
timeFrame: Baseline to 24 weeks
measure: TCM facial diagnosis estimated by tongue-face diagnosis instrument
timeFrame: Baseline to 24 weeks
measure: Health-related quality of life
timeFrame: Baseline to 24 weeks
measure: Diet
timeFrame: Baseline to 24 weeks
measure: Binge eating behaviors
timeFrame: Baseline to 24 weeks
measure: Diet and eating behaviors
timeFrame: Baseline to 24 weeks
measure: Psychological status-Anxiety
timeFrame: Baseline to 24 weeks
measure: Psychological status-Depression
timeFrame: Baseline to 24 weeks
measure: Sleep quality
timeFrame: Baseline to 24 weeks
measure: Metabolomic profiling performed by liquid chromatography mass spectrometry
timeFrame: Baseline to 24 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Endocrinology, Shanghai Municipal Hospital of Traditional Chinese Medicine
state: Shanghai
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Victor Wenze Zhong, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Endocrinology, Shanghai Municipal Hospital of Traditional Chinese Medicine
name: Feng Tao, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: