NCT01476384

Brief Summary

Aging is accompanied by a progressive loss of skeletal muscle mass and strength, leading to the loss of functional capacity and an increased risk of developing chronic metabolic disease. One of these metabolic diseases interacting with muscle mass is Diabetes Mellitus type 2. Diabetes Mellitus type 2 is characterized by high blood glucose in the context of insulin resistance and relative insulin deficiency. It has become clear that amongst its many actions, insulin is also a vasoactive hormone. Its effect to cause endothelial-nitric oxide dependent vasodilation is physiologic and dose dependent. Recent data suggest that insulin's metabolic and vascular actions are closely linked. This also means that an increase in microvascular perfusion following food intake is more resistant to postprandial insulin release. This physiological process is brought into prominence with increasing age, and even more in type 2 diabetics, and contributes to diminishing glycaemic control. In the present study the investigators will investigate the impact of postprandial insulin release on microvascular recruitment in the oral cavity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Oct 2010

Longer than P75 for not_applicable type-2-diabetes-mellitus

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

October 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 22, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 11, 2014

Status Verified

April 1, 2014

Enrollment Period

3.3 years

First QC Date

November 14, 2011

Last Update Submit

April 10, 2014

Conditions

Type 2 Diabetes Mellitus

Keywords

GlucoseinsulinGlycocalyxMuscleVascularisationyoungelderly

Outcome Measures

Primary Outcomes (1)

  • Glycocalyx permeability

    Changes in glycocalyx permeability in young, elderly and type 2 diabetics after ingestion of a glucose or water (placebo) drink. The glycocalyx will be measured during 2 h after ingestion of the drink.

    30 minutes after ingestion of the drink

Secondary Outcomes (1)

  • Microvascular density

    3 h after ingestion of glucose drink

Study Arms (2)

Glucose drink

EXPERIMENTAL

75 gram glucose, dissolved in 250 ml water

Dietary Supplement: Glucose

Placebo

PLACEBO COMPARATOR

250 ml water

Dietary Supplement: Placebo

Interventions

GlucoseDIETARY_SUPPLEMENT

Glucose drink: 75 gram dextrose monohydrate, dissolved in 250 ml water

Also known as: GLU
Glucose drink
PlaceboDIETARY_SUPPLEMENT

250 ml water

Also known as: PLA
Placebo

Eligibility Criteria

Age20 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male
  • Aged between 20-30 or 65-80 years
  • BMI \< 30 kg/m2
  • Non insulin-dependent Diabetes mellitus type 2 patients. Use of oral anti-diabetic agents (TZD's, Metformin and/or a sulfonylurea derivative) is allowed.

You may not qualify if:

  • Positive history for hypertension
  • Smoking
  • Hypertension (according to WHO criteria)18
  • Use of medication, except for oral blood glucose lowering medication
  • All co morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthrosis, arthritis, spasticity/rigidity, all neurological disorders and paralysis).
  • HbA1c \> 10.0%
  • Diagnosed impaired renal or liver function
  • Obesity (BMI\>30 kg/m2)
  • Cardiac disease or cardiovascular problems in history
  • Overt diabetic complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center+

Maastricht, Limburg, 6229ER, Netherlands

Location

Related Publications (1)

  • Groen BB, Hamer HM, Snijders T, van Kranenburg J, Frijns D, Vink H, van Loon LJ. Skeletal muscle capillary density and microvascular function are compromised with aging and type 2 diabetes. J Appl Physiol (1985). 2014 Apr 15;116(8):998-1005. doi: 10.1152/japplphysiol.00919.2013. Epub 2014 Feb 27.

    PMID: 24577061DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin ResistanceNeovascularization, Pathologic

Interventions

Glucose

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinismMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • LJC van Loon, Professor

    Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2011

First Posted

November 22, 2011

Study Start

October 1, 2010

Primary Completion

January 1, 2014

Study Completion

March 1, 2014

Last Updated

April 11, 2014

Record last verified: 2014-04

Locations

NL(1)