Type 2 Diabetes MellitusNCT00951912

The Effects of Soy Isoflavones to Improve the Metabolism of Glucose and Lipids

A study testing Daidzein and Genistein in people with Type 2 Diabetes Mellitus, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 30 to 70 years, women only
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Daidzein and Genistein
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 165 participants
Where: 1 siteChina
Study dates: Aug 2009to Sep 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 70 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Chinese women aged 30-70 y
Fasting glucose >=5.6 mmol/l; post-load glucose >=7.8 mmol/l

Who cannot join

Diabetes renal diseases
Confirmed CVD, chronic liver,kidney diseases,Thyroid disease
Medications affecting glucose or lipid metabolism

Trial locations and contacts

1 site in 1 country.

China1 site

The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080

Other trials in China

About this study

Official title: The Study of the Effects of Soy Isoflavones on the Metabolism of Glucose and Lipids in Postmenopausal Chinese Women With Impaired Glucose Regulation

Many studies showed that soy foods or soy isoflavones can lower the risk of cardiovascular disease (CVD), osteoporosis and some cancers, but few human studies assessed effects of purified isoflavone components (genistein and daidzein) on glucose metabolism. This double-blinded, randomized, placebo-controlled trial will examine the effects of purified genistein and daidzein on glucose metabolism in prediabetic or diabetic women. One hundred and eighty eligible women age 30-70 years(without any treatment of diabetic drugs) will be recruited and randomly allocated into the following three arms: Placebo (10g isolated soy protein, ISP); Genistein (10g ISP + 50mg genistein); Daidzein (10g ISP + 50mg daidzein) per day for 6 mo. Fasting glucose, lipids, insulin, inflammation marks and post-load for glucose and insulin will be determined at 0, 3th, and 6th month. Changes in these indices will be compared among the three groups.

Read the detailed description

Subjects were Chinese adult women, age 30-70 year, with an FG concentration ranging from 5.6 to 7.0 mmol/L or 2-h PG concentration ranging from 7.8-11.0 mmol/L or with newly diagnosed diabetes not requiring medication treatment according to a doctor's suggestion or participants did not willing to take medication themselves, and managed their diabetes just with a stable diet and exercise. Women were excluded if they had a history of coronary heart disease, stoke, thyroid disease, severe liver, lung, or gastrointestinal tract diseases; were currently or in the past 8 weeks used hypoglycemic or lipid-lowering or weight-reduction agents; were occurrence of diabetic complications; use of hormone replacement therapy; allergy to soy;were long-term antibiotics users.

Conditions: Type 2 Diabetes Mellitus
Being tested: Placebo, Daidzein, Genistein
Keywords: genistein, daidzein, impaired glucose regulation, glucose metabolism, lipids metabolism, inflammation, women
Medical subject headings: Diabetes Mellitus, Type 2, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDietary supplement
10g soy protein isolated per day
DaidzeinDietary supplement
50mg daidzein +10g soy protein isolated per day
GenisteinDietary supplement
50mg genistein +10g soy protein isolated per day

Study groups in NCT00951912
Study group	Role	What they receive
Placebo	Placebo comparator	10g soy protein isolated powder patch by mouth everyday for 6months Receives: Dietary Supplement: Placebo
Daidzein	Experimental	10g soy protein isolated plus 50mg daidzein powder patch by mouth everyday for 6 months Receives: Dietary Supplement: Daidzein
Genistein	Experimental	10g soy protein isolated plus 50mg genistein powder patch by mouth everyday for 6 months Receives: Dietary Supplement: Genistein

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage Change in Fasting Plasma Glucose
(6th month value-baseline value)/baseline value*100%
Measured: Baseline,6 months
Percentage Change in 120-minutes Postload Plasma Glucose
(6th month value-baseline value)/baseline*100%
Measured: Baseline, 6 months
Percentage Change in HbA1C
(6th month value-baseline value)/baseline value*100%
Measured: Baseline, 6 months
Percentage Change in AUC of Glucose
values were from 75g glucose oral glucose tolerance test and caculated as (6th month value-baseline value)/baseline value*100%
Measured: Baseline, 6 months
Percentage Change in Fasting Plasma Insulin
(6th month value-baseline value)/baseline value*100%
Measured: Baseline, 6 months
Percentage Change in HOMA-IR
HOMA-IR was calculated with the homeostasis model assessment for insulin resistance,and it is caculated as the following equation: HOMA-IR=FIns×FG/22.5, where FIns represents fasting insulin in microunits per milliliter, and FG is in millimoles per liter. The percentage change was caculated as (6th month value-baseline value)/baseline value*100%
Measured: Baseline, 6 months
Percentage Change in QUICKI
QUICKI is the abbreviation of Quantitative Insulin Sensitivity Check Index,and it is a marker to evaluate insulin sensitivity in HOMA model.It is calculated by using the following equation: 1/(logFIns +logFG),where FIns represents fasting insulin in microunits per milliliter, and FG is in millimoles per liter.
The percentage change was caculated as (6th month value-baseline value)/baseline value*100%
Measured: Baseline, 6 months
Percentage Change in Total Cholesterol
(6th month value-baseline value)/baseline value*100%
Measured: Baseline, 6 months
Percentage Change in Triglyceride
(6th month value-baseline value)/baseline value*100%
Measured: Baseline, 6 months
Percentage Change in High Density Lipoprotein Cholesterol
(6th month value-baseline value)/baseline value*100%
Measured: Baseline, 6 months
Percentage Change in Low Density Lipoprotein Cholesterol
(6th month value-baseline value)/baseline value*100%
Measured: Baseline, 6 months

Secondary outcomes (4)

Total Urinary Isoflavones
Measured: 3 months
Urinary Daidzein
Urinary daidzein excretion
Measured: 3 months
Urinary Genistein
Urinary genistein excretion
Measured: 3 months
Total Energy Intake at Follow-up
The energy intake was evaluated by 3 days dietary records.
Measured: an average of the 24 weeks follow-up period which were evalutated on baseline,12 week and 24 week.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2009Sep 2011

First posted4 Aug 2009 (estimated)
Study startAug 2009
Primary completionJun 2011
Study completionSep 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 165 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00951912
Sponsor's protocol ID: yanbinye
Status last verified: Oct 2012
First submitted: 3 Aug 2009
Last updated: 17 Oct 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Study of the Effects of Soy Isoflavones on the Metabolism of Glucose and Lipids in Postmenopausal Chinese Women With Impaired Glucose Regulation
ClinicalTrials.gov ID: NCT00951912
Acronym / sponsor ID: yanbinye
Conditions: Type 2 Diabetes Mellitus
Keywords: genistein, daidzein, impaired glucose regulation, glucose metabolism, lipids metabolism, inflammation, women
Study type: Interventional
Recruitment status: Completed
Enrolment: 165 participants (actual)
Lead sponsor: Sun Yat-sen UniversityUniversity, hospital or other
Collaborators: Chinese Nutrition Society, Danone Institute International, Department of Health of Guangdong Province
Study start: Aug 2009
Primary completion: Jun 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 4 Aug 2009 (estimated)
Results: Posted 16 Oct 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Dietary Supplement: Placebo10g soy protein isolated powder patch by mouth everyday for 6months
Daidzein	Experimental	Dietary Supplement: Daidzein10g soy protein isolated plus 50mg daidzein powder patch by mouth everyday for 6 months
Genistein	Experimental	Dietary Supplement: Genistein10g soy protein isolated plus 50mg genistein powder patch by mouth everyday for 6 months

Who may qualify

Ages: 30 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Chinese women aged 30-70 y
Fasting glucose >=5.6 mmol/l; post-load glucose >=7.8 mmol/l

Key exclusion criteria (3 listed)

Diabetes renal diseases
Confirmed CVD, chronic liver,kidney diseases,Thyroid disease
Medications affecting glucose or lipid metabolism

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Placebo10g soy protein isolated per day	Dietary supplement	Placebo
Daidzein50mg daidzein +10g soy protein isolated per day	Dietary supplement	Daidzein
Genistein50mg genistein +10g soy protein isolated per day	Dietary supplement	Genistein

Primary outcome

Percentage Change in Fasting Plasma Glucose
Time frame: Baseline,6 months
(6th month value-baseline value)/baseline value*100%
Percentage Change in 120-minutes Postload Plasma Glucose
Time frame: Baseline, 6 months
(6th month value-baseline value)/baseline*100%
Percentage Change in HbA1C
Time frame: Baseline, 6 months
(6th month value-baseline value)/baseline value*100%
Percentage Change in AUC of Glucose
Time frame: Baseline, 6 months
values were from 75g glucose oral glucose tolerance test and caculated as (6th month value-baseline value)/baseline value*100%
Percentage Change in Fasting Plasma Insulin
Time frame: Baseline, 6 months
(6th month value-baseline value)/baseline value*100%
Percentage Change in HOMA-IR
Time frame: Baseline, 6 months
HOMA-IR was calculated with the homeostasis model assessment for insulin resistance,and it is caculated as the following equation: HOMA-IR=FIns×FG/22.5, where FIns represents fasting insulin in microunits per milliliter, and FG is in millimoles per liter. The percentage change was caculated as (6th month value-baseline value)/baseline value*100%
Percentage Change in QUICKI
Time frame: Baseline, 6 months
QUICKI is the abbreviation of Quantitative Insulin Sensitivity Check Index,and it is a marker to evaluate insulin sensitivity in HOMA model.It is calculated by using the following equation: 1/(logFIns +logFG),where FIns represents fasting insulin in microunits per milliliter, and FG is in millimoles per liter. The percentage change was caculated as (6th month value-baseline value)/baseline value*100%
Percentage Change in Total Cholesterol
Time frame: Baseline, 6 months
(6th month value-baseline value)/baseline value*100%
Percentage Change in Triglyceride
Time frame: Baseline, 6 months
(6th month value-baseline value)/baseline value*100%
Percentage Change in High Density Lipoprotein Cholesterol
Time frame: Baseline, 6 months
(6th month value-baseline value)/baseline value*100%
Percentage Change in Low Density Lipoprotein Cholesterol
Time frame: Baseline, 6 months
(6th month value-baseline value)/baseline value*100%

4 secondary outcomes

Total Urinary Isoflavones
Time frame: 3 months
Urinary Daidzein
Time frame: 3 months
Urinary Genistein
Time frame: 3 months
Total Energy Intake at Follow-up
Time frame: an average of the 24 weeks follow-up period which were evalutated on baseline,12 week and 24 week.

Results and safety

Results posted to the registry on 16 Oct 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	54	47
Daidzein	55	50
Genistein	56	54

Primary outcome: Percentage Change in Fasting Plasma Glucose

Time frame: Baseline,6 months. Mean (Standard Deviation). Unit: percentage of change

Measure	Placebo Group n = 54	Daidzein Group n = 55	Geinstein Group n = 56
Value	-1.80 (13.5)	-1.00 (12.61)	-4.89 (11.79)

Placebo Group vs Daidzein Group: Mean Difference (Net): -0.7981 (95% CI -6.6569 to 5.0607), p <0.05, ANOVA
Placebo Group vs Geinstein Group: Mean Difference (Net): 3.0842 (95% CI -2.7486 to 8.9171), p <0.05, ANOVA
Daidzein Group vs Geinstein Group: Mean Difference (Net): 3.8823 (95% CI -1.9234 to 9.6881), p <0.05, ANOVA

Population analysed: the number of participants for analysis was determined by intention to treat

Primary outcome: Percentage Change in 120-minutes Postload Plasma Glucose

Time frame: Baseline, 6 months. Mean (Standard Deviation). Unit: percentage of change

Measure	Placebo Group n = 54	Daidzein Group n = 55	Geinstein Group n = 56
Value	-4.90 (20.67)	-3.13 (20.60)	-5.59 (24.23)

Placebo Group vs Daidzein Group: Mean Difference (Net): -1.7696 (95% CI -11.9308 to 8.3916), p <0.05, ANOVA
Placebo Group vs Geinstein Group: Mean Difference (Net): 0.6929 (95% CI -9.4232 to 10.8091), p <0.05, ANOVA
Daidzein Group vs Geinstein Group: Mean Difference (Net): 2.4626 (95% CI -7.6067 to 12.5318), p <0.05, ANOVA

Population analysed: All participants were determinted by intention to treat

Primary outcome: Percentage Change in HbA1C

Time frame: Baseline, 6 months. Mean (Standard Deviation). Unit: percentage of change

Measure	Placebo Group n = 54	Daidzein Group n = 55	Geinstein Group n = 56
Value	-1.38 (7.17)	-1.37 (5.99)	-1.30 (9.29)

Placebo Group vs Daidzein Group: Mean Difference (Net): -0.01174 (95% CI -3.5428 to 3.5194), p <0.05, ANOVA
Placebo Group vs Geinstein Group: Mean Difference (Net): -2.68659 (95% CI -6.2020 to 0.8288), p <0.05, ANOVA
Daidzein Group vs Geinstein Group: Mean Difference (Net): -2.67485 (95% CI -6.174 to 0.8243), p <0.05, ANOVA

Population analysed: The number of participants analyzed was determinted by intention to treat.

Primary outcome: Percentage Change in AUC of Glucose

Time frame: Baseline, 6 months. Mean (Standard Deviation). Unit: percentage of change

Measure	Placebo Group n = 54	Daidzein Group n = 55	Geinstein Group n = 56
Value	-6.23 (14.06)	-3.27 (16.98)	-5.24 (17.96)

Placebo Group vs Daidzein Group: Mean Difference (Net): -2.9661 (95% CI -10.5857 to 4.6535), p <0.05, ANOVA
Placebo Group vs Geinstein Group: Odds Ratio, log: -0.9972 (95% CI -8.5830 to 6.5886), p <0.05, ANOVA
Daidzein Group vs Geinstein Group: Median Difference (Net): 1.9689 (95% CI -5.5817 to 9.5195), p <0.05, ANOVA

Population analysed: The number of patticipants was determinted by intention to treat

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: We collected 10 cases of other adverse events which were mild to moderate in severity in the 6 months intervention period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 54 (0%)	4 of 54 (7.4%)	Not reported
Daidzein	0 of 55 (0%)	4 of 55 (7.3%)	Not reported
Genistein	0 of 56 (0%)	2 of 56 (3.6%)	Not reported

Limitations and caveats (from the sponsor): A relative long time of recruitment leading to a little different in dietary intakes among subjects;The menstrual period will leading to different estradiol;The different severity of the diabetes leading to the different dropout percentage.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Type 2 Diabetes Mellitus

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yan-bin Ye, MD principal investigator

Sun Yat-sen University

Yu-ming Chen, PhD study director

Sun Yat-sen University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Daidzein and Genistein in people with Type 2 Diabetes Mellitus, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Change in Fasting Plasma Glucose (time frame: Baseline,6 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00951912.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2012.