NCT01298375|UnknownDMC
Metabolic Phenotyping in Humans
MetPhe
Metabolic Characterization of Type 2 Diabetic, Obese, Lean Sedentary and Endurance Trained Individuals in Vivo, ex Vivo and in Vitro
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MetPhe
Metabolic Characterization of Type 2 Diabetic, Obese, Lean Sedentary and Endurance Trained Individuals in Vivo, ex Vivo and in Vitro
Sponsor study identifier
observational
132
1 country
1
Study Start
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 16, 2011
Actual (reported)February 17, 2011
Actual (reported)March 2011
Date type not reportedThis date has not been verified as actual or estimated.
March 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Euglycemic-hyperinsulinemic clamp for measurement of insulin sensitivity and metabolic flexibility
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. Before and during steady state, substrate oxidation is measured using an indirect calorimeter, which determines metabolic flexibility.
10 hours
Evaluating mitochondrial function through measurement of phosphocreatine (PCr) recovery by phosphorus magnetic resonance spectroscopy (31P-MRS) within the skeletal muscle
1.5 hours
Human volunteers from the surrounding area
Maastricht University
Maastricht, Limburg, 6200MD, Netherlands
Mancilla RF, Lindeboom L, Grevendonk L, Hoeks J, Koves TR, Muoio DM, Schrauwen P, Schrauwen-Hinderling V, Hesselink MK. Skeletal muscle mitochondrial inertia is associated with carnitine acetyltransferase activity and physical function in humans. JCI Insight. 2023 Jan 10;8(1):e163855. doi: 10.1172/jci.insight.163855.
Houzelle A, Jorgensen JA, Schaart G, Daemen S, van Polanen N, Fealy CE, Hesselink MKC, Schrauwen P, Hoeks J. Human skeletal muscle mitochondrial dynamics in relation to oxidative capacity and insulin sensitivity. Diabetologia. 2021 Feb;64(2):424-436. doi: 10.1007/s00125-020-05335-w. Epub 2020 Nov 30.
DNA, RNA, tissue, primary myoblasts, mitochondria
Patrick Schrauwen, PhD
Maastricht University
Lauren M Sparks, PhD
Maastricht University
Madeleen Bosma, M.S.
Maastricht University
First Submitted
February 16, 2011
First Posted
February 17, 2011
Study Start
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2024
Estimated (date passed)Green Tea, High in Epigallocatechin Gallate (EGCG) and Postprandial Fat Oxidation
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 19, 2022
Record last verified: 2022-09
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