- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01940302
Dietary Supplement of LEHEL for the Patients With Type 2 Diabetes
Metabolic Control Before and After Supplementation With LEHEL in Patients With Type 2 Diabetes
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Tidlig fase 1
Kontakter og lokationer
Studiesteder
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Guangdong
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Shaoguan, Guangdong, Kina, 512005
- Shaoguan University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
Subject is diagnosed with type 2 diabetes mellitus according to the Chinese type 2 diabetes prevention guide 2010, diagnostic criteria are as follows:
(1) Diabetes symptoms(polydipsia、polyphagia, polyuria, weight loss、skin itching、blurred vision and other acute metabolic network disorder that caused by high blood sugar)combined with random blood sugar ≥11.1 OR, (2) fasting plasma glucose (FPG) ≥7.0 OR, (3) 2 h blood sugar after oral glucose tolerance test (OGTT) ≥11.1;
- Subject is between 18 and 75 years of age, inclusive.
- Subject's BMI is >18.5 kg/m2 and <35 kg/m2.
- If on a chronic medication such as anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, subject has been on constant dosage for at least two months prior to screening visit.
Exclusion Criteria:
- Subject that is diagnosed as type 1 diabetes, gestational diabetes and other kinds of diabetes expect type 2.
- Subject that use exogenous insulin for glucose control.
- Subject that has a history of diabetic ketoacidosis.
- Subject that has mental disorder, cancer, cirrhosis, renal disease and hepatic disease.
- Subject that has had a significant cardiovascular event less than six months prior to screening visit or has history of congestive heart failure.
- Subject that has had operation less than six months prior to screening visit.
- Subject that has taken/is currently taking any dietary supplements or medications that could profoundly affect blood glucose during the past one month prior to screening visit.
- Subject is known to be allergic or intolerant to any ingredient found in the study product.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: LEHEL multi-nutrients supplement
75 g/d of LEHEL supplementation along with oral hypoglycemic agents such as glibenclamide and/or metformin.
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The primary objective of this study is to evaluate the effect of a diet program including LEHEL multi-nutrients supplement as breakfast replacement on metabolic control after 12-week intervention in subjects with type 2 diabetes.
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Ingen indgriben: Control
Received only oral hypoglycemic agents.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Metabolic Control
Tidsramme: Twelve weeks
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Hemoglobin A1c (HbA1c) and lipids (Cholesterol, HDL-cholesterol, Triglycerides) at study entry and 12 weeks after dietary intervention
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Twelve weeks
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Wenhua Ling, Ph.D., Sun Yat-sen University
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SGU-03
- 2012BAD33B10 (Anden identifikator: National Key Technology Research and Development Program of China)
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