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

25. september 2020 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

61

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention group
The Light-Fat Rice® group
Kosttilskud: 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 komparator: Control group
The comparable energy staple food group
Kosttilskud: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Dynamic blood glucose changes (average blood glucose)
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Blood glucose control compliance rate
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Blood lipid changes
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Peking Union Medical College Hospital

Samarbejdspartnere

Hebei Dongfangyun Health Management Co.,Ltd

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. juni 2019

Primær færdiggørelse (Faktiske)

20. juni 2020

Studieafslutning (Forventet)

20. juli 2021

Datoer for studieregistrering

Først indsendt

24. maj 2019

Først indsendt, der opfyldte QC-kriterier

2. juni 2019

Først opslået (Faktiske)

4. juni 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. september 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. september 2020

Sidst verificeret

1. september 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HS-1910

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ja

IPD-planbeskrivelse

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-delingstidsramme

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

IPD-delingsadgangskriterier

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

IPD-deling Understøttende informationstype

  • Studieprotokol
  • Statistisk analyseplan (SAP)
  • Klinisk undersøgelsesrapport (CSR)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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