A Clinical Trial of Overweight/Obesity With Type 2 Diabetes

NCT03972904 | Unknown DMC

• 1 other identifier: HS-1910
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Overweight and Obesity

Keywords

Diabetes Mellitus,Type 2; Overweight; Obesity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Blood glucose control compliance rate

  Baseline time, week 4

• Glycated albumin changes

  Baseline time, week 4

Other Outcomes (2)

• Blood lipid changes

  Baseline time, week 4

• BMI changes

  Baseline time, week 2,week 4

Study Arms (2)

Intervention group

EXPERIMENTAL

The Light-Fat Rice® group

Dietary Supplement: Light-Fat Rice® combined with Active Peptide®+ lifestyle guidance

Control group

PLACEBO COMPARATOR

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

Interventions

Light-Fat Rice® combined with Active Peptide®+ lifestyle guidance DIETARY_SUPPLEMENT

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.

Intervention group

A staple food of comparable energy containing a small amount of dietary fiber combined with a comparable energy maltodextrin + lifestyle guidance DIETARY_SUPPLEMENT

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.

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Hebei Dongfangyun Health Management Co.,Ltd: collaborator

Study Sites (1)

Dongcheng district，Peking union medical college hospital

Beijing, Beijing Municipality, 100010, China

Location

Related Publications (5)

• 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.

  PMID: 14500058 BACKGROUND

• 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.

  PMID: 26879684 BACKGROUND

• 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.

  PMID: 29221645 BACKGROUND

• 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.

  PMID: 30852132 BACKGROUND

• 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.

  PMID: 15139891 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Overweight; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; 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

Study Officials

• Wei Chen, M.D.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Peking Union Medical College Hospital,Clinical Nutrition Department,Chief Physician

Model Details: 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.

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: June 4, 2019
• Study Start: June 20, 2019
• Primary Completion: June 20, 2020
• Study Completion: July 20, 2021
• Last Updated: September 28, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The data is expected to be available after June，20, 2020 and can be used forever.
• Access Criteria: The information should be used for academic research, medical communication, etc., and is prohibited from being used for commercial gain.

Locations

CN (1)