NCT02072759

Brief Summary

Insulin resistant subjects and type 2 diabetic patients are characterized by a decreased metabolic flexibility: a reduced capability to switch from fat oxidation in the basal state to carbohydrate oxidation in the insulin-stimulated state. This metabolic inflexibility is an early hallmark in the development of diabetes. Recent evidence suggests that a low carnitine availability may limit acetylcarnitine formation, thereby reducing metabolic flexibility. We propose to test the hypothesis that metabolic inflexibility in pre-diabetic subjects and diabetic patients is due to a reduced capacity to form acetylcarnitines.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 14, 2016

Status Verified

June 1, 2015

Enrollment Period

2.3 years

First QC Date

February 25, 2014

Last Update Submit

July 13, 2016

Conditions

Glucose Intolerance

Keywords

Insulin sensitivityMetabolic flexibility

Outcome Measures

Primary Outcomes (2)

  • metabolic flexibility

    delta RER between basal and insulin-stimulated state)

    36 days

  • Insulin sensitivity

    36 days

Secondary Outcomes (4)

  • exercise-induced acetylcarnitine concentrations

    36 days

  • meal-induced acetylcarnitine formation

    36 days

  • CrAT activity

    36 days

  • fasted blood plasma levels of FFA, triglycerides and glucose and post-meal area under the curve (AUC)

    36 days

Other Outcomes (3)

  • Maximal aerobic capacity (VO2max)

    screening

  • Body composition (DEXA)

    screening

  • Glucose tolerance (OGTT)

    screening

Study Arms (3)

Carnitine supplement

EXPERIMENTAL

Carnitine supplement

Dietary Supplement: Carnitine supplement

Placebo

PLACEBO COMPARATOR

Placebo supplement

Dietary Supplement: Placebo

Healthy control

NO INTERVENTION

Healthy control group

Interventions

Carnitine supplementDIETARY_SUPPLEMENT

Carnitine supplement (oral ingestion with meals) Total dosage of 2g carnitine per day for 36 days. * 1 carnitine supplement at breakfast (500mg) * 1 carnitine supplement at lunch (500mg) * 2 carnitine supplements at diner (2x 500mg=1000mg)

Carnitine supplement
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 40-70 years
  • Overweight/obese, BMI 25-35 kg/m2
  • Stable dietary habits
  • Generally healthy with no medication use that interferes with metabolism

You may not qualify if:

  • Fasting plasma glucose \>7.1 mmol/l
  • Haemoglobin \<7.8 mmol/l
  • Hypertension: blood pressure \> 140 mmHg systolic or 90 mmHg diastolic
  • Cardiac problems, such as angina pectoris, cardiac infarction and arrhythmias
  • Plasma creatinine concentration higher than 115 micromol/l (in men) en 100 micromol (in women).
  • Any medical condition requiring treatment and/or medication that interferes with investigated parameters
  • Unstable body weight (weight gain or loss \> 3 kg in the past three months)
  • Participation in another biomedical study within 1 month prior to the screening visit
  • Subjects with contra-indication for MRI
  • Subjects, who do not want to be informed about unexpected medical findings, or do not wish that their treating physician is informed, cannot participate in the study.
  • Subject are not allowed to donate blood three months prior to the start of the study and three months after finishing the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229 ER, Netherlands

Location

MeSH Terms

Conditions

Glucose IntoleranceInsulin Resistance

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperinsulinism

Study Officials

  • Vera B Schrauwen, PhD

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 25, 2014

First Posted

February 27, 2014

Study Start

March 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

July 14, 2016

Record last verified: 2015-06

Locations

NL(1)