A Clinical Trial of Overweight/Obesity With Type 2 Diabetes

Study Overview
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Brief Summary
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In the previous intervention studies of Type 2 Diabetes Mellitus patients, changes in blood glucose and insulin resistance profiles before and after intervention indicated that different intervention methods had different effects on outcomes. Therefore, this study intends to explore the effect of the Light-Fat Rice®combined with Active Peptide® on the level of insulin resistance in overweight/obese diabetic patients and its effect on the outcome through a 4-week, randomized, double-blind, controlled clinical trial, further elucidating its intervention mechanism theoretically. The study predicts that dynamic blood glucose(mean blood glucose) and glycosylated albumin will significantly different between the control group and the intervention group.And insulin resistance levels, blood lipids and other indicators wil be improved, and the test group was superior to the control group.All of these will contribute to more scientific and effective Type 2 Diabetes Mellitus's management.

Detailed Description
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The prevalence of Type 2 Diabetes Mellitus is increasing year by year in the world, causing harm to patients' health and making a huge consumption of medical expenses. Obesity is one of the most obvious risk factors for Type 2 Diabetes Mellitus. There are also many positive studies on nutritional intervention for the treatment of obese patients with Type 2 Diabetes Mellitus at home and abroad. The effect of nutritional meal replacement to relieve the disease has also been widely recognized. Light-Fat Rice® is a new type of nutritious staple food taking rice, konjac, marine fish oligopeptide powder, inulin and yeast as raw material. Also,there is a protein solid beverage,Active Peptide®,containing soy protein isolate, soy peptide powder, oligofructose,water-soluble dietary fiber and other ingredients,such as multi-vitamin. When used together, it can provide balanced nutrition for the human body while satisfying low fat and high protein. In this study, a 4-week, randomized, double-blind, controlled clinical trial will be conducted to investigate the effects of Light-Fat Rice® combined with Active Peptide® intervention on insulin resistance in overweight/obese diabetic patients and their effects on prognosis,further explaining its intervention mechanism theoretically. Based on a previous review of similar literature studies, 60 of these patients will be enrolled and randomly assigned to the intervention and control groups at 1:1. Among them, the intervention group will be given 80g of Light-Fat Rice® staple food meal as an independent staple food or mixed in the staple food combined with 2 packs Active Peptide®, and the control group was given the same energy-equivalent staple food produced by the same manufacturer daily with 2 packs maltodextrin. Both groups are provided with a same lifestyle guidance by professional physicians based on the Guidelines for the Prevention and Treatment of Type 2 Diabetes in China 2017, including reasonable diet, exercise guidance, and organization of health education.

Official Title
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Effect of Light-Fat Rice® on Blood Glucose in Overweight/Obese Patients With Type 2 Diabetes Mellitus and Related Mechanisms

Conditions
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Diabetes Mellitus, Type 2, Overweight and Obesity

Intervention / Treatment
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* Dietary Supplement: Light-Fat Rice® combined with Active Peptide®+ lifestyle guidance
* Dietary Supplement: A staple food of comparable energy containing a small amount of dietary fiber combined with a comparable energy maltodextrin + lifestyle guidance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Comply with the diagnostic criteria for type 2 diabetes in the 1999 WHO Diabetes Diagnosis and Classification Standard: Clear clinical record of fasting blood glucose (FPG) ≥ 7mmol / L or 75g OGTT（2h） ≥ 11.1mmol / L; T2DM of duration > 1 year（diagnosis based on the 1999 WHO Diabetes Diagnosis and Classification Standard in China ）; Body mass index: 25 kg/m2 < BMI ≤ 35kg/m2; Men and women aged 18-75 years; Volunteer to participate in the trial and sign the informed consent form . Exclusion Criteria: Acute cardiovascular and cerebrovascular events or myocardial infarction within previous 6 months; Laboratory inspection: Liver function: AST and / or ALT ≥ 2.5 × ULN; Renal function: Cr>1.2×ULN; People with severe gastrointestinal diseases, such as active peptic ulcer, intestinal obstruction, etc.;have a history of changes in the normal structure of the gastrointestinal tract; Hypertensive patients with poor blood pressure control(blood pressure SBP≥160mmHg and / or DBP≥100mmHg); Those with severe blood system diseases; Combine other endocrine system diseases(such as hyperthyroidism or hypercortisolism); Patients with stress or secondary blood glucose elevation(such as taking glucocorticoids); Pregnant or lactating women,and women who are not willing to contraception during pregnancy or study; Food or other drug abusers; People who may be allergic to the test food; Those who have participated in other food trials within 3 months; Those who cannot co-operate with mental illness; Other circumstances,which the researcher believes that it is not suitable for the group.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The diet will be administered by a professional physician (intervention group:Light-Fat Rice® combined with Active Peptide®; control group: staple food of equal energy containing a small amount of dietary fiber combined with comparable energy maltodextrin) with a lifestyle guidance,same in both groups, to assist in diabetes management. The method of taking the product can be divided into two parts.And a dynamic blood glucose transient monitor would be worn for all patients at the 3rd week to record the patients's dynamic blood glucose changes including preprandial, postprandial (every 15 minutes), before and after exercise (every 30 minutes).Besides these,the patients would be asked to record dietary and exercise diary for 3 days(including one weekend at least) each week also.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>The Light-Fat Rice® group | Dietary Supplement: Light-Fat Rice® combined with Active Peptide®+ lifestyle guidance<br>* Subjects will be given the Light-Fat Rice® combined with Active Peptide® with a lifestyle guidance to assist diabetes management. The method of taking the product has two parts: 1.Light-Fat Rice®: 80g (1 pack) per day as a staple meal replacement, used as a separate staple food or mixed with other staple foods, taking 4 weeks; 2.Active Peptide®: 20g (2 packs) per day (1 pack each morning and evening), served with 300ml of 40°C warm water each time before meals and take it for 4 weeks.<br>|
| Placebo Comparator: Control group<br>The comparable energy staple food group | Dietary Supplement: A staple food of comparable energy containing a small amount of dietary fiber combined with a comparable energy maltodextrin + lifestyle guidance<br>* A staple food of comparable energy containing a small amount of dietary fiber combined with a comparable energy maltodextrin (both produced by the same manufacturer) with a lifestyle guidance will be given by the professional to assist in diabetes management. The product is taken as follows: 1.equal-energy staple food containing a small amount of dietary fiber: 80g (1 pack) per day, used as an independent staple food or mixed with other staple foods, taking for 4 weeks; 2.equal-energy maltodextrin: 20g(2 packs) per day(1 pack each morning and evening),take it with 300ml of 40°C warm water for 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamic blood glucose changes (average blood glucose) | Patients will be exposed to a dynamic glycemic transient monitor from the 3rd week of the study period, worn for 2 weeks, and removed at the 4th week of follow-up. During the period of wearing, the patients will be required to record the dietary diary, preprandial and postprandial (every 15 minutes) blood glucose level (mmol/L) for 3-day period (including one day of the weekend)each week, and also select 3 days per week (including one day of the weekend) to record daily exercise, pre- and post-exercise (every 30 minutes) blood glucose levels (mmol/L) . | week 3,week 4 | 
| Insulin resistance index changes | The patients will be subjected to two blood collections throughout the study, at baseline and at the 4th week of follow-up. The insulin resistance index is calculated as HOMA-IR=［plasma glucose（GLU,mmol/L）*serum insulin(mIU/L)］/22.5. | Baseline time, week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose control compliance rate | The patients will be subjected to two blood collections throughout the study, at baseline and at the 4th week of follow-up. The glycemic control compliance rate will be compared using two fasting blood glucose values and expressed as a number (percentage). | Baseline time, week 4 | 
| Glycated albumin changes | The patients will be subjected to two blood collections throughout the study, at baseline and at the 4th week of follow-up. The change in glycated albumin (GA%) will be compared with the values of two fasting blood samples, with a normal range of 10.8%-17.1%. | Baseline time, week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus,Type 2, Overweight, Obesity