NCT01298375: MetPhe

Metabolic Characterization of Type 2 Diabetic, Obese, Lean Sedentary and Endurance Trained Individuals in Vivo, ex Vivo and in Vitro

Status unknown Last updated 16 September 2022

What this trial tests

trial in Healthy in 132 participants. Status unknown.

Timeline

1 March 2011

Primary endpoint
1 March 2024

1 March 2024

Quick facts

Lead sponsor	Maastricht University Medical Center
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	132
Start date	1 March 2011
Primary completion	1 March 2024
Estimated completion	1 March 2024
Sites	1 location across Netherlands

Conditions studied

• Healthy — all drugs for Healthy →
• Obesity — all drugs for Obesity →
• Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →

Sponsor

Maastricht University Medical Center

Who can join

Adults 18 to 70, male only, with Healthy or Obesity. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Euglycemic-hyperinsulinemic clamp for measurement of insulin sensitivity and metabolic flexibility
  Time frame: 10 hours
  After taking fasting blood samples, a primed constant infusion of glucose is initiated. Plasma glucose levels are clamped at \~5 mmol/L by variable co-infusion of 20% glucose. Every 5 minutes, blood is sampled for immediate determination of plasma glucose concentration. Glucose infusion rate is adjusted to obtain plasma glucose levels of \~5 mmol/L (euglycemia). A bolus of insulin is then infused.

Sponsor's own description

Type 2 diabetes (T2D) is a global burden disease affecting almost 200 million people and is expected to nearly double by 2030 (1). It is imperative that this disease is kept under control, and that we begin to reverse the direction of its incidence. We propose to start by identifying the physiological and molecular aspects of the problem in all spectrums of the disease (ie from insulin sensitive athletes to sedentary lean and obese individuals and further to overt type 2 diabetics), and focus our efforts on examining the differences and identifying the stages of progression for possible targets of future intervention. The proposed study "Metabolic Phenotyping" is novel in its target populations and innovative in its use of state-of-the-art techniques. We hypothesize that the in vivo differences in metabolic flexibility and mitochondrial function between endurance athletes and type 2 diabetics and their lean and obese controls are retained in vitro and will offer a new model in which to study the underlying mechanisms of the progression of T2D.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Human skeletal muscle mitochondrial dynamics in relation to oxidative capacity and insulin sensitivity.
   Houzelle A, Jörgensen JA, Schaart G, Daemen S, et al · · 2021 · cited 64× · PMID 33258025 · DOI 10.1007/s00125-020-05335-w
2. Evaluation of Muscle microRNA Expression in Relation to Human Peripheral Insulin Sensitivity: A Cross-Sectional Study in Metabolically Distinct Subject Groups.
   Dahlmans D, Houzelle A, Jörgensen JA, Phielix E, et al · · 2017 · cited 27× · PMID 28983252 · DOI 10.3389/fphys.2017.00711
3. MicroRNA-204-5p modulates mitochondrial biogenesis in C2C12 myotubes and associates with oxidative capacity in humans.
   Houzelle A, Dahlmans D, Nascimento EBM, Schaart G, et al · · 2020 · cited 21× · PMID 32452584 · DOI 10.1002/jcp.29797
4. An unbiased silencing screen in muscle cells identifies miR-320a, miR-150, miR-196b, and miR-34c as regulators of skeletal muscle mitochondrial metabolism.
   Dahlmans D, Houzelle A, Andreux P, Jörgensen JA, et al · · 2017 · cited 21× · PMID 29107290 · DOI 10.1016/j.molmet.2017.08.007
5. Reduced incorporation of fatty acids into triacylglycerol in myotubes from obese individuals with type 2 diabetes.
   Sparks LM, Bosma M, Brouwers B, van de Weijer T, et al · · 2014 · cited 17× · PMID 24487026 · DOI 10.2337/db13-1123
6. Skeletal muscle mitochondrial inertia is associated with carnitine acetyltransferase activity and physical function in humans.
   Mancilla RF, Lindeboom L, Grevendonk L, Hoeks J, et al · · 2023 · cited 9× · PMID 36413408 · DOI 10.1172/jci.insight.163855