NCT01940302

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P75+ for early_phase_1 type-2-diabetes

Timeline
Completed

Started Jun 2013

Shorter than P25 for early_phase_1 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

May 12, 2014

Status Verified

May 1, 2014

Enrollment Period

6 months

First QC Date

September 7, 2013

Last Update Submit

May 8, 2014

Conditions

Type 2 Diabetes

Keywords

Malnutrition; Metabolic disorders

Outcome Measures

Primary Outcomes (1)

  • Metabolic Control

    Hemoglobin A1c (HbA1c) and lipids (Cholesterol, HDL-cholesterol, Triglycerides) at study entry and 12 weeks after dietary intervention

    Twelve weeks

Study Arms (2)

LEHEL multi-nutrients supplement

EXPERIMENTAL

75 g/d of LEHEL supplementation along with oral hypoglycemic agents such as glibenclamide and/or metformin.

Dietary Supplement: LEHEL multi-nutrients supplement

Control

NO INTERVENTION

Received only oral hypoglycemic agents.

Interventions

LEHEL multi-nutrients supplementDIETARY_SUPPLEMENT

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.

LEHEL multi-nutrients supplement

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaoguan University

Shaoguan, Guangdong, 512005, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2MalnutritionMetabolic Diseases

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersNutritional and Metabolic DiseasesEndocrine System DiseasesNutrition Disorders

Study Officials

  • Wenhua Ling, Ph.D.

    Sun Yat-sen University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2013

First Posted

September 12, 2013

Study Start

June 1, 2013

Primary Completion

December 1, 2013

Study Completion

March 1, 2014

Last Updated

May 12, 2014

Record last verified: 2014-05

Locations

CN(1)