Clinical trial NCT03972904: A Clinical Trial of Overweight/Obesity With Type 2 Diabetes
Official title: Effect of Light-Fat Rice® on Blood Glucose in Overweight/Obese Patients With Type 2 Diabetes Mellitus and Related Mechanisms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Overweight and Obesity
Keywords: Diabetes Mellitus,Type 2
Overweight
Obesity
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Hebei Dongfangyun Health Management Co.,Ltd
First posted: 2019-06-04
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. 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;
2. T2DM of duration \> 1 year（diagnosis based on the 1999 WHO Diabetes Diagnosis and Classification Standard in China ）;
3. Body mass index: 25 kg/m2 \< BMI ≤ 35kg/m2;
4. Men and women aged 18-75 years;
5. Volunteer to participate in the trial and sign the informed consent form .

Exclusion Criteria:

1. Acute cardiovascular and cerebrovascular events or myocardial infarction within previous 6 months;
2. Laboratory inspection:

   Liver function: AST and / or ALT ≥ 2.5 × ULN; Renal function: Cr\>1.2×ULN;
3. 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;
4. Hypertensive patients with poor blood pressure control(blood pressure SBP≥160mmHg and / or DBP≥100mmHg);
5. Those with severe blood system diseases;
6. Combine other endocrine system diseases(such as hyperthyroidism or hypercortisolism);
7. Patients with stress or secondary blood glucose elevation(such as taking glucocorticoids);
8. Pregnant or lactating women,and women who are not willing to contraception during pregnancy or study;
9. Food or other drug abusers;
10. People who may be allergic to the test food;
11. Those who have participated in other food trials within 3 months;
12. Those who cannot co-operate with mental illness;
13. Other circumstances,which the researcher believes that it is not suitable for the group.

Primary outcomes:
measure: Dynamic blood glucose changes (average blood glucose)
timeFrame: week 3,week 4
measure: Insulin resistance index changes
timeFrame: Baseline time, week 4
Secondary outcomes:
measure: Blood glucose control compliance rate
timeFrame: Baseline time, week 4
measure: Glycated albumin changes
timeFrame: Baseline time, week 4
Other outcomes:
measure: Blood lipid changes
timeFrame: Baseline time, week 4
measure: BMI changes
timeFrame: Baseline time, week 2,week 4
Locations:
city: Beijing
country: China
facility: Dongcheng district，Peking union medical college hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Wei Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ryan DH, Espeland MA, Foster GD, Haffner SM, Hubbard VS, Johnson KC, Kahn SE, Knowler WC, Yanovski SZ; Look AHEAD Research Group. Look AHEAD (Action for Health in Diabetes): design and methods for a clinical trial of weight loss for the prevention of cardiovascular disease in type 2 diabetes. Control Clin Trials. 2003 Oct;24(5):610-28. doi: 10.1016/s0197-2456(03)00064-3.
citation: Leslie WS, Ford I, Sattar N, Hollingsworth KG, Adamson A, Sniehotta FF, McCombie L, Brosnahan N, Ross H, Mathers JC, Peters C, Thom G, Barnes A, Kean S, McIlvenna Y, Rodrigues A, Rehackova L, Zhyzhneuskaya S, Taylor R, Lean ME. The Diabetes Remission Clinical Trial (DiRECT): protocol for a cluster randomised trial. BMC Fam Pract. 2016 Feb 16;17:20. doi: 10.1186/s12875-016-0406-2.
citation: Lean ME, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Stefanetti R, Trenell M, Welsh P, Kean S, Ford I, McConnachie A, Sattar N, Taylor R. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet. 2018 Feb 10;391(10120):541-551. doi: 10.1016/S0140-6736(17)33102-1. Epub 2017 Dec 5.
citation: Lean MEJ, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Welsh P, Kean S, Ford I, McConnachie A, Messow CM, Sattar N, Taylor R. Durability of a primary care-led weight-management intervention for remission of type 2 diabetes: 2-year results of the DiRECT open-label, cluster-randomised trial. Lancet Diabetes Endocrinol. 2019 May;7(5):344-355. doi: 10.1016/S2213-8587(19)30068-3. Epub 2019 Mar 6.
citation: Laws R; Counterweight Project Team. A new evidence-based model for weight management in primary care: the Counterweight Programme. J Hum Nutr Diet. 2004 Jun;17(3):191-208. doi: 10.1111/j.1365-277X.2004.00517.x.