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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02095873
Other study ID # PJT_HATFF
Secondary ID TSB101129
Status Completed
Phase Phase 1/Phase 2
First received March 18, 2014
Last updated June 8, 2015
Start date May 2014
Est. completion date May 2015

Study information

Verified date June 2015
Source University of Warwick
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics CommitteeUnited Kingdom: Research Councils UKUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether dietary inducers of glyoxalase 1 are effective in improving metabolic and vascular health.


Description:

The aim of the study is to evaluate dietary inducers of glyoxalase 1 for effects on metabolic and vascular health in overweight volunteers at risk of developing type 2 diabetes. The research objectives are:

(i) To evaluate dietary inducers of glyoxalase 1 for effects on markers of glucose metabolism during an oral glucose tolerance test (oGTT), (ii) To evaluate dietary inducers of glyoxalase 1 for effects on vascular function on three levels, using finger fold capillary density by capillaroscopy (FFCD), arterial stiffness by aortal pulse wave velocity (aPWV) and flow mediated dilatation (FMD); and effects on metabolic and pro-inflammatory markers in circulating blood and urine.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date May 2015
Est. primary completion date February 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- BMI 25 - 40 kg/m2 (>23 kg/m2 for Asians), with normal, impaired fasting or impaired postprandial glucose.

- No other relevant morbidities.

- Women will be preferably post-menopausal.

Exclusion Criteria:

- Severe hypertriglyceridemia.

- Uncontrolled hypertension, cardiovascular disease, relevant renal or hepatic disease, diabetes, and other relevant morbidity.

- Excess alcohol consumption, smoking, acute pharmacological treatment with drugs affecting glucose metabolism such as steroids and antibiotics.

- Anticoagulants.

- Intake of herbal remedies.

- Food allergies.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Glyoxalase 1 inducer
Dietary bioactive
Placebo
Mannitol, 210 mg

Locations

Country Name City State
United Kingdom University Hospitals Coventry & Warwickshire NHS Trust (UHCW) Coventry Warwickshire

Sponsors (3)

Lead Sponsor Collaborator
University of Warwick Technology Strategy Board, United Kingdom, Unilever R&D

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Rabbani N, Thornalley PJ. Dicarbonyl stress in cell and tissue dysfunction contributing to ageing and disease. Biochem Biophys Res Commun. 2015 Mar 6;458(2):221-6. doi: 10.1016/j.bbrc.2015.01.140. Epub 2015 Feb 7. Review. — View Citation

Xue M, Rabbani N, Momiji H, Imbasi P, Anwar MM, Kitteringham N, Park BK, Souma T, Moriguchi T, Yamamoto M, Thornalley PJ. Transcriptional control of glyoxalase 1 by Nrf2 provides a stress-responsive defence against dicarbonyl glycation. Biochem J. 2012 Apr 1;443(1):213-22. doi: 10.1042/BJ20111648. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Change in aortal pulse wave velocity (aPWV) Aortal pulse wave velocity is measured by a non-invasive oscillometric device. 0, 8, 14 and 22 weeks No
Other Change in flow-mediated dilatation (FMD) Brachial artery FMD will be assessed. Ultrasound imaging of the brachial artery will be performed. Percent FMD will be calculated using the averaged minimum mean brachial artery diameter at baseline compared to the largest mean values obtained after either release of the forearm occlusion. 0, 8, 14 and 22 weeks No
Primary Change in oral glucose tolerance test (oGGT) A standard 75 g glucose oGTT will be performed, as routinely used in clinical practice. Participants will be instructed to eat carbohydrate rich diet (> 150 g/day) for at least three days before the test, followed by an overnight fast. Participants will be instructed to have comparable macronutrient composition of the dinner before the respective study days in the metabolic unit. During the oGTT both capillary and venous blood samples will be collected after 0, 15, 30, 60, 90 and 120 min. To minimize the inconvenience of repeated blood tests during the oGTT, a venous cannula will be inserted, under sterile conditions, prior to the test, for blood sampling. Weeks 0, 8, 14 and 22 No
Secondary Change in finger-fold capillary density by capillaroscopy After 20 min seated at rest, measurements are made with the subject seated and the left hand at heart level. Nail-fold capillaries in the dorsal skin of the third finger are visualized using a stereo microscope linked to a monochrome digital camera. Capillary density is defined as the number of capillaries per mm2 of nail-fold skin and is computed as the mean of 4 measurements. 0, 8, 14 and 22 weeks No
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