Dietary Supplement of LEHEL for the Patients With Type 2 Diabetes

Early Phase 1

Completed

• Conditions: Type 2 Diabetes
• Interventions: Dietary Supplement: LEHEL multi-nutrients supplement

• Registration Number: NCT01940302
• Lead Sponsor: Shaoguan University

Brief Summary

Due to metabolic disorders and dietary restrictions, patients with diabetes may have different degrees of malnutrition. The primary objective of this study is to investigate whether supplementation of LEHEL, a multi-nutrients supplement, is capable to improve metabolic parameters in patients with type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-09-07
• Study First Submitted QC: 2013-09-07
• Study First Posted: 2013-09-12
• Primary Completion: 2013-12
• Study Completion: 2014-03
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-08
• Last Update Posted: 2014-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LEHEL multi-nutrients supplement	LEHEL multi-nutrients supplement	75 g/d of LEHEL supplementation along with oral hypoglycemic agents such as glibenclamide and/or metformin.

Primary Outcome Measures

Name	Time	Method
Metabolic Control	Twelve weeks	Hemoglobin A1c (HbA1c) and lipids (Cholesterol, HDL-cholesterol, Triglycerides) at study entry and 12 weeks after dietary intervention

Trial Locations

Locations (1)

Shaoguan University; 🇨🇳 Shaoguan, Guangdong, China