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A Clinical Trial of Overweight/Obesity With Type 2 Diabetes (ELFOOD)

25 september 2020 bijgewerkt door: Wei Chen, Peking Union Medical College Hospital

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

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.

Studie Overzicht

Toestand

Onbekend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

61

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • China
    • Beijing
      • Beijing, Beijing, China, 100010
        • Dongcheng district，Peking union medical college hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 75 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Intervention group
The Light-Fat Rice® group
Voedingssupplement: Light-Fat Rice® combined with Active Peptide®+ lifestyle guidance
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.
Placebo-vergelijker: Control group
The comparable energy staple food group
Voedingssupplement: A staple food of comparable energy containing a small amount of dietary fiber combined with a comparable energy maltodextrin + lifestyle guidance
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Dynamic blood glucose changes (average blood glucose)
Tijdsspanne: week 3,week 4
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
Tijdsspanne: Baseline time, week 4
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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Blood glucose control compliance rate
Tijdsspanne: Baseline time, week 4
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
Tijdsspanne: Baseline time, week 4
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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Blood lipid changes
Tijdsspanne: Baseline time, week 4
The patients will be subjected to two blood collections throughout the study, at baseline and at the 4th week of follow-up. Changes in blood lipids (total cholesterol, mmol/L;triglycerides, mmol/L;high-density lipoprotein cholesterol, mmol/L; low-density lipoprotein cholesterol, mmol/L) will be compared using the values of two fasting blood samples. The normal range is 2.85-5.70 mmol/L for total cholesterol, 0.45-1.70 mmol/L for triglycerides, 1.42-11.29 mmol/L for high-density lipoprotein cholesterol, and 2.07-3.62 mmol/L for low-density lipoprotein cholesterol.
Baseline time, week 4
BMI changes
Tijdsspanne: Baseline time, week 2,week 4
Patients will be subjected to three body weight measurements throughout the study, baseline, week 2, and week 4 of follow-up,along with their height measurements at the start of the study. Both of the height and weight will be measured with a standard instrument and recorded in meters and kilograms respectively，following a requirement of accurating to two decimal places. And the weight and height will be combined to report in a form of BMI in kg/m^2.The changes in BMI before and after the study will be expressed as mean ± SD.
Baseline time, week 2,week 4

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Peking Union Medical College Hospital

Medewerkers

Hebei Dongfangyun Health Management Co.,Ltd

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

20 juni 2019

Primaire voltooiing (Werkelijk)

20 juni 2020

Studie voltooiing (Verwacht)

20 juli 2021

Studieregistratiedata

Eerst ingediend

24 mei 2019

Eerst ingediend dat voldeed aan de QC-criteria

2 juni 2019

Eerst geplaatst (Werkelijk)

4 juni 2019

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 september 2020

Laatste update ingediend die voldeed aan QC-criteria

25 september 2020

Laatst geverifieerd

1 september 2020

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • HS-1910

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Ja

Beschrijving IPD-plan

The following data will be shared at the end of the study: demographic data, current medical history, past history; physical examination data collected at 3 visits, including heart rate, blood pressure, height, weight, waist circumference, hip circumference, grip strength, and human body Ingredients, etc.; previous physical examination data provided at baseline such as abdominal ultrasound; laboratory tests such as insulin levels, blood lipid levels, urinary protein levels collected at baseline and 4th week of follow-up; dietary and exercise diaries as well as the dynamic blood sugar changes along with these, etc.

IPD-tijdsbestek voor delen

The data is expected to be available after June，20, 2020 and can be used forever.

IPD-toegangscriteria voor delen

The information should be used for academic research, medical communication, etc., and is prohibited from being used for commercial gain.

IPD delen Ondersteunend informatietype

  • Leerprotocool
  • Statistisch Analyse Plan (SAP)
  • Klinisch onderzoeksrapport (CSR)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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