Condition category
Nutritional, Metabolic, Endocrine
Date applied
03/10/2010
Date assigned
25/10/2010
Last edited
25/10/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Changhao Sun

ORCID ID

Contact details

157 Baojian Road
Nangang District
Harbin
150081
China
+86 (0)451 8750 2801
sun2002changhao@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2009007

Study information

Scientific title

Effects of curcuminoids on blood glucose, lipids, serum adipocyte fatty acid-binding protein and lipoprotein lipase in patients with type 2 diabetes: a double-blind, placebo-controlled trial

Acronym

Study hypothesis

The natural compounds curcuminoids, including curcumin, demethoxycurcumin and bisdemethoxycurcumin, have a broad spectrum of health benefits including hypolipidemic, hypoglycemic effects. As diabetes is associated with impaired lipid metabolism, the improvement of lipid profile may explain at least in part the benefits of curcuminoids on diabetes.

Our previous study confirmed that curcumin improved insulin resistance in part by decreasing plasma FFAs and increasing fatty acid oxidation in skeletal muscle of diabetic rats. However, reports about the effect of curcuminoids on type 2 diabetes in human are extremely limited.

We hypothesized that curcuminoids would increase insulin sensitivity partly by promoting fatty acid oxidation in patients with type 2 diabetes.

Ethics approval

Medical Ethics Committe of Public Health College, Harbin Medical University, approved on 20th September 2009 (ref: 2009007)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Type 2 diabetes

Intervention

Eligible subjects were first sorted by blood glucose concentration and then randomised into two groups with a block size of 2, with random numbers generated by SPSS.

The subjects in the curcuminoids group received a 150 mg curcuminoid capsule twice daily (30 minutes after breakfast and supper respectively) for a total intake of 300 mg/d curcuminoids (the purity had been confirmed to be 97.49% by HPLC: curcumin 36.06%; demethoxycurcumin, 18.85%; bisdemethoxycurcumin, 42.58%).

The subjects in placebo group took capsules with placebo (starch) instead of curcuminoids at the same frequency and amount.

The intervention lasted for 3 months.

Intervention type

Drug

Phase

Not Applicable

Drug names

Curcuminoids

Primary outcome measures

1. The effects of curcuminoids on glucose metabolism: fasting glucose and insulin, 2-hour post prandial glucose , HOMA-IR and HbA1c(%)
2. The effects of curcuminoids on lipis metabolism:
2.1. Serum cholesterol, triacylglycerol, HDL-C, LDL-C, Apo A-I and Apo B
2.2. Serum LPL and AFABP
2.3. Serum FFA profile
2.4. Severity of fatty liver

Secondary outcome measures

1. Baseline characteristics: age, gender, BMI, waist circumference, waist-to-hip ratio, diabetes duration, blood pressure, drug treatment, cigarette use and physical activity level
2. Daily intake of nutrients by the subjects at baseline and after 3-month intervention
3. Blood biochemistry characteristics of the subjects at baseline and after 3-month intervention: red blood cell, white blood cell, hemoglobin, total protein, albumin, urea nitrogen, creatinine, alanine transaminase and aspartate transminase

Overall trial start date

10/10/2009

Overall trial end date

10/01/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 - 65 years, both male and female
2. Type 2 diabetes with fasting blood glucose greater than or equal to 7.0 mmol/L or postprandial blood glucose greater than or equal to 11.1 mmol/L
3. Current optimal therapeutic regimens lasting for at least 6 months

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. A history of type 1 diabetes, malignancies, thyroid or any other endocrine diseases likely to interfere with the study
2. Diabetic ketosis acidosis and infection in recent 3 months
3. Pregnancy or breastfeeding
4. Information incompleted or unwillingness to attempt to comply with the intervention

Recruitment start date

10/10/2009

Recruitment end date

10/01/2010

Locations

Countries of recruitment

China

Trial participating centre

157 Baojian Road
Harbin
150081
China

Sponsor information

Organisation

Public Health College - Harbin Medical University (China)

Sponsor details

c/o Changhao Sun
157 Baojian Road
Nangang District
Harbin
150081
China
+86 (0)451 8750 2801
sun2002changhao@yahoo.com

Sponsor type

University/education

Website

http://yxzy.hrbmu.edu.cn/gongwei/

Funders

Funder type

Government

Funder name

National Natural Science Foundation of China (China) (ref: 30810107)

Alternative name(s)

National Science Foundation of China, Natural Science Foundation of China, NSFC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

China

Funder name

National High Technology Research and Development Program of China (China) - 863 program) (ref: 2010AA023002)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Scientific Research Fund of Heilongjiang Provincial Education Department (China) (ref: 1154z1007)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes