Resveratrol and First-degree Relatives of Type 2 Diabetic Patients

Pre-diabetes Clinical Trial

Official title:

Effects of Resveratrol on Insulin Sensitivity, Brown Adipose Tissue and Metabolic Profile in First-degree Relatives of Type 2 Diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02129595
• Other study ID #: 13-3-058
• Status: Completed
• Phase: N/A
• First received: April 24, 2014
• Last updated: August 7, 2017
• Start date: April 2014
• Est. completion date: July 31, 2017

Study information

• Verified date: August 2016
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of the study is to investigate if resveratrol supplementation can improve overall and muscle-specific insulin sensitivity in first-degree relatives of type 2 diabetic patients.

As a secondary objective the investigators want to investigate whether the improved insulin sensitivity can be attributed to improved muscle mitochondrial oxidative capacity and a reduced intrahepatic and cardiac lipid content. Furthermore, in a subset of the participants the investigators want to investigate the effect of resveratrol on glucose uptake in brown adipose tissue.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 31, 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• Male sex

• Age: 40-70 years

• BMI 27-35 kg/m2

• Has first-degree relative(s) diagnosed with type 2 diabetes

• Sedentary

• Not more than 2 hours of sports a week

• No active job that requires strenuous physical activity

• Stable dietary habits: no weight gain or loss > 5kg in the last three months

• Insulin resistant: glucose clearance rate below < 350 ml/kg/min, as determined using OGIS120

• Willingness to abstain from resveratrol-containing food products

• Subjects will only be included when the dependent medical doctor of this study approves participation after evaluating data obtained during screening

Exclusion Criteria:

• Use of anticoagulants

• Uncontrolled hypertension

• Haemoglobin <7.8 mmol/l

• In case of an abnormal ECG in rest: this will be discussed with the responsible medical doctor

• HBA1C > 6.5%

• Diagnosed with type 2 diabetes

• Medication use known to interfere with glucose homeostasis/metabolism

• Current alcohol consumption > 20 grams/day

• Subjects who don't want to be informed about unexpected medical findings during the screening /study, or do not wish that their physician is informed, cannot participate in the study.

• Subjects who intend to donate blood during the intervention or subjects who have donated blood less than three months before the start of the intervention.

• Participation in another biomedical study within 1 month before the first screening visit

• Any condition, disease or abnormal laboratory test result that, in the opinion of the Investigator, would interfere with the study outcome, affect trial participation or put the subject at undue risk

• Any contra-indication to MRI scanning. These contra-indications include patients with following devices:

• Central nervous system aneurysm clip

• Implanted neural stimulator

• Implanted cardiac pacemaker of defibrillator

• Cochlear implant

• Insulin pump

• Metal containing corpora aliena in the eye or brains

Related Conditions & MeSH terms

• Glucose Intolerance
• Pre-diabetes
• Prediabetic State

Intervention

Dietary Supplement:
• placebo
A placebo will given for 30 days or 34 days (if included in brown adipose tissue measurement), twice daily. One pill will be provided with lunch, and the other pill will be provided with dinner.
• resveratrol
resveratrol will be given for 30 days or 34 days (if included in brown adipose tissue measurement), twice daily. One pill, which contains 75 mg of resveratrol, will be provided with lunch, and the other pill, also containing 75 mg will be given with dinner. So in total a dose of 150 mg/day will be given.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre	Maastricht	Limburg

Sponsors (3)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Diabetes Fonds, DSM Nutritional Products, Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maximal aerobic capacity (VO2max)		27 days after supplementation
Other	Blood pressure		30 days after supplementation
Primary	insulin sensitivity: overall, muscle- and liver specific	Hyperinsulinemic euglycemic clamp combined with indirect calorimetry: Glucose infusion rate (GIR), rate of appearance and disappearance of glucose (Ra, Rd), endogenous glucose production (EGP), oxidative and non-oxidative glucose disposal, carbohydrate and lipid oxidation, energy expenditure.	30 days after supplementation
Secondary	muscle mitochondrial oxidative capacity (in vivo and ex vivo)	In vivo: Phosphocreatine levels will be measured by P-MRS (before, during, and after exercise) as a marker for in vivo mitochondrial function in the vastus lateralis muscle.; Ex vivo mitochondrial function in skeletal muscle will be measured by oxygen consumption in muscle fibres (muscle biopsy) on lipid-derived and carbohydrate-derived substrates.	30 days after supplementation
Secondary	intramyocellular lipid content	Skeletal muscle lipid accumulation measured by immunohistochemistry in muscle biopsy from vastus lateralis muscle	30 days after supplementation
Secondary	intrahepatic lipid content	Intrahepatic lipid content measured with H-MRS	30 days after supplementation
Secondary	intracardiac lipid content	Intracardiac lipid content measured with H-MRS	30 days after supplementation
Secondary	heart function	Cardiac function: diastolic and systolic heart function will be measured with ultrasound	30 days after supplementation
Secondary	brown adipose tissue activity	subjects will be exposed to an individualized cooling protocol, after which an 18F-FDG PET/CT scan is made	34 days after supplementation