Carnitine Supplementation in Type 2 Diabetic Patients

NCT03230812 | Completed DMC

• 1 other identifier: NL62791.068.17
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

the results from animal studies and preliminary human studies show that carnitine availability and acetylcarnitine concentrations are low in insulin resistant states such as with type 2 diabetes mellitus. However, in humans, carnitine supplementation is sometimes beneficial, but not in everyone. We hypothesize that this variability in response might be due to differences between individuals in the amount of carnitine in the muscle i.e. subjects with a low initial carnitine status will benefit more from supplementation. The state of the art non-invasive magnetic resonance spectroscopy method allows us to identify patients muscle acetylcarnitine status. Here we aim to test whether carnitine improves insulin sensitivity, furthermore, whether acetylcarnitine concentration at baseline or other characteristics are associated with the response (in insulin sensitivity) to carnitine supplementation. Furthermore, we will examine the potentially positive effect of carnitine supplementation in type 2 diabetes patients on intrahepatic lipid content, acetylcarnitine formation, blood plasma metabolites, body composition, physical performance and quality of life

Conditions

Glucose Intolerance

Keywords

Insulin sensitivity; Metabolic flexibility

Outcome Measures

Primary Outcomes (2)

• Insulin sensitivity

  Whole body insulin sensitivity measured as GIR in µmol/kg/min during the stable period of the insulin phase of the clamp. * Hepatic insulin sensitivity measured as percent EGP supression in µmol/kg/min. * Peripheral insulin sensitivity measured as Rd in µmol/kg/min.

  2-step hyperinsulinemische-egulycemische clamp (5.5 hours)

• Metabolic flexibility

  delta RER between basal and insulin stimulated state (both low (10mU) and high (40mU) insulin state

  2-step hyperinsulinemische-egulycemische clamp (5.5 hours)

Secondary Outcomes (8)

• Maximal acetylcarnitine concentrations after exercise

  45 minutes

• Body composition (bod pod)

  30 minutes

• Intrahepatic lipid content

  45 minutes

• physical performance

  6 minutes

• physical performance

  5 minutes

Other Outcomes (1)

• Maximal aerobic capacity

  20 minutes

Study Arms (1)

Experimental: carnitine intervention (in all participants)

EXPERIMENTAL

All subjects will undergo oral Carnitene (L-Carnitine or levocarnitine) supplementation for 96 days.The total dosage of L-carnitine per day will be 2970mg. Consumption of the chewing tablets will be divided over the day. Intake of these chewing tablets will be during breakfast (990mg), lunch (990mg) and during diner (990mg). Since the chewing tablets are only available in concentrations of 330mg, participants have to consume 3 chewing tablets per meal, a total of 9 chewing tablets each day.

Drug: Carnitene (L-Carnitine or Levocarnitine)

Interventions

Carnitene (L-Carnitine or Levocarnitine) DRUG

All subjects will undergo oral Carnitene (L-Carnitine or levocarnitine) supplementation for 96 days.The total dosage of L-carnitine per day will be 2970mg. Consumption of the chewing tablets will be divided over the day. Intake of these chewing tablets will be during breakfast (990mg), lunch (990mg) and during diner (990mg). Since the chewing tablets are only available in concentrations of 330mg, participants have to consume 3 chewing tablets per meal, a total of 9 chewing tablets each day.

Experimental: carnitine intervention (in all participants)

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and woman
• Age: 40-75 years
• Woman should be postmenopausal
• BMI: 25-38 kg/m2
• Stable dietary habits
• No use of medication interfering with investigated study parameters (as determined by responsible physician)
• Use of oral glucose lowering medication (metformin only or in combination with sulfonylurea agents)

You may not qualify if:

• Haemoglobin levels \< 7.8 mmol/L
• Uncontrolled hypertension
• Use of anticoagulants
• Insulin dependent type 2 diabetic patients.
• No signs of active liver or kidney malfunction.
• Engagement in exercise \> 3 hours a week
• Being vegetarian or vegan (because of altered whole body carnitine status)
• Alcohol and/or drug abuse
• Unstable body weight (weight gain or loss \> 5kg in the last 3 months)
• Significant food allergies/intolerances (seriously hampering study meals)
• Participation in another biomedical study within 1 month before the first study visit, which would possibly hamper our study results
• Medication use known to hamper subject's safety during the study procedures
• Subjects with contra-indications for MRI
• Subjects who intend to donate blood during the intervention or subjects who have donated blood less than three months before the start of the study
• Subjects who do not want to be informed about unexpected medical findings

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University

Maastricht, Limburg, 6229ER, Netherlands

Location

MeSH Terms

Conditions

Glucose Intolerance; Insulin Resistance

Interventions

Carnitine

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Study Officials

• Vera Schrauwen, Dr

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One group with type 2 diabetic patients who will undergo oral L-carnitine supplementation for 96 days

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: July 26, 2017
• Study Start: March 1, 2018
• Primary Completion: November 11, 2019
• Study Completion: November 11, 2019
• Last Updated: December 7, 2020

Record last verified: 2020-12

Locations

NL (1)