NCT02122666

Brief Summary

The investigators previous research has suggested that lipid (fatty) composition in the muscle cells of mice plays a key role in their insulin sensitivity. The purpose of this study is to determine whether these specific fat signatures translate to humans by comparing the muscle of healthy patients to those with pre-diabetes, or "the metabolic syndrome".

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2014

Longer than P75 for all trials

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

March 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2014

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2024

Completed
8 months until next milestone

Results Posted

Study results publicly available

October 26, 2024

Completed
Last Updated

October 26, 2024

Status Verified

August 1, 2024

Enrollment Period

10 years

First QC Date

April 22, 2014

Results QC Date

February 15, 2024

Last Update Submit

August 8, 2024

Conditions

Metabolic Syndrome

Keywords

Metabolic SyndromePre-diabetesimpaired glucose tolerancePhospholipids

Outcome Measures

Primary Outcomes (1)

  • Sarcoplasmic Reticulum Composition

    We will take a muscle tissue sample from the subject's thigh (vastus lateralis) to quantify phosphatidylcholine to phosphatidylethanolamine ratio of the sarcoplasmic reticulum.

    Study Visit Week 4

Secondary Outcomes (2)

  • Insulin Sensitivity

    Study visit week 4

  • Lean and Fat Body Mass

    Study Visit week 4

Study Arms (2)

Metabolic Syndrome

Muscle biopsy to determine sarcoplasmic reticulum composition and function, Oral Glucose tolerance test with insulin levels at time points to determine Insulin sensitivity, DEXA scan to determine lean muscle and fat mass

Procedure: muscle biopsy

Control

Muscle biopsy to determine sarcoplasmic reticulum composition and function, Oral Glucose tolerance test with insulin levels at time points to determine Insulin sensitivity, DEXA scan to determine lean muscle and fat mass

Procedure: muscle biopsy

Interventions

muscle biopsyPROCEDURE

A member of the study team will obtain a small sample of muscle tissue from the patient's thigh (vastus lateralis muscle).

ControlMetabolic Syndrome

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

primary care clinic, community sample

You may qualify if:

  • Sedentary: No routine exercise, walking \<10,000 steps per day Age \>18 and \<65 Body Mass Index (BMI) \<32 Healthy by physical exam (patient is devoid of major acute or chronic illness) No significant abnormality in screening labs

You may not qualify if:

  • Currently on any significant prescription medications other than oral contraceptives in women Currently Pregnant Current Tobacco Use
  • Subjects with the Metabolic Syndrome
  • Sedentary: No routine exercise, walking \<10,000 steps per day Age \>18 and \<65 Body Mass Index (BMI) \>30
  • Meet at least three of the following Adult Treatment Panel (ATP) III criteria for the metabolic syndrome:
  • waist circumference \> or = 40 inches in men, \> or = 35 inches in women blood triglycerides \> or = 150 mg/dL blood HDL cholesterol \<40 mg/dL in men, \<50 in women blood pressure \> or = 130 mmHg systolic, or \> or = 85 mmHg diastolic fasting blood sugar \> or = 100 mg/dL
  • Diagnosed with Type 2 diabetes, coronary artery disease, cancer, liver, lung, or kidney disease or any other major illness
  • Currently on any significant prescription medications other than:
  • oral contraceptives in women More than two standard medication for stage 1 hypertension in men or women (blood pressure 140-159/90-99) Currently Pregnant Current Tobacco Use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (7)

  • Lozano R, Naghavi M, Foreman K, Lim S, Shibuya K, Aboyans V, Abraham J, Adair T, Aggarwal R, Ahn SY, Alvarado M, Anderson HR, Anderson LM, Andrews KG, Atkinson C, Baddour LM, Barker-Collo S, Bartels DH, Bell ML, Benjamin EJ, Bennett D, Bhalla K, Bikbov B, Bin Abdulhak A, Birbeck G, Blyth F, Bolliger I, Boufous S, Bucello C, Burch M, Burney P, Carapetis J, Chen H, Chou D, Chugh SS, Coffeng LE, Colan SD, Colquhoun S, Colson KE, Condon J, Connor MD, Cooper LT, Corriere M, Cortinovis M, de Vaccaro KC, Couser W, Cowie BC, Criqui MH, Cross M, Dabhadkar KC, Dahodwala N, De Leo D, Degenhardt L, Delossantos A, Denenberg J, Des Jarlais DC, Dharmaratne SD, Dorsey ER, Driscoll T, Duber H, Ebel B, Erwin PJ, Espindola P, Ezzati M, Feigin V, Flaxman AD, Forouzanfar MH, Fowkes FG, Franklin R, Fransen M, Freeman MK, Gabriel SE, Gakidou E, Gaspari F, Gillum RF, Gonzalez-Medina D, Halasa YA, Haring D, Harrison JE, Havmoeller R, Hay RJ, Hoen B, Hotez PJ, Hoy D, Jacobsen KH, James SL, Jasrasaria R, Jayaraman S, Johns N, Karthikeyan G, Kassebaum N, Keren A, Khoo JP, Knowlton LM, Kobusingye O, Koranteng A, Krishnamurthi R, Lipnick M, Lipshultz SE, Ohno SL, Mabweijano J, MacIntyre MF, Mallinger L, March L, Marks GB, Marks R, Matsumori A, Matzopoulos R, Mayosi BM, McAnulty JH, McDermott MM, McGrath J, Mensah GA, Merriman TR, Michaud C, Miller M, Miller TR, Mock C, Mocumbi AO, Mokdad AA, Moran A, Mulholland K, Nair MN, Naldi L, Narayan KM, Nasseri K, Norman P, O'Donnell M, Omer SB, Ortblad K, Osborne R, Ozgediz D, Pahari B, Pandian JD, Rivero AP, Padilla RP, Perez-Ruiz F, Perico N, Phillips D, Pierce K, Pope CA 3rd, Porrini E, Pourmalek F, Raju M, Ranganathan D, Rehm JT, Rein DB, Remuzzi G, Rivara FP, Roberts T, De Leon FR, Rosenfeld LC, Rushton L, Sacco RL, Salomon JA, Sampson U, Sanman E, Schwebel DC, Segui-Gomez M, Shepard DS, Singh D, Singleton J, Sliwa K, Smith E, Steer A, Taylor JA, Thomas B, Tleyjeh IM, Towbin JA, Truelsen T, Undurraga EA, Venketasubramanian N, Vijayakumar L, Vos T, Wagner GR, Wang M, Wang W, Watt K, Weinstock MA, Weintraub R, Wilkinson JD, Woolf AD, Wulf S, Yeh PH, Yip P, Zabetian A, Zheng ZJ, Lopez AD, Murray CJ, AlMazroa MA, Memish ZA. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2095-128. doi: 10.1016/S0140-6736(12)61728-0.

    PMID: 23245604BACKGROUND

  • Finucane MM, Stevens GA, Cowan MJ, Danaei G, Lin JK, Paciorek CJ, Singh GM, Gutierrez HR, Lu Y, Bahalim AN, Farzadfar F, Riley LM, Ezzati M; Global Burden of Metabolic Risk Factors of Chronic Diseases Collaborating Group (Body Mass Index). National, regional, and global trends in body-mass index since 1980: systematic analysis of health examination surveys and epidemiological studies with 960 country-years and 9.1 million participants. Lancet. 2011 Feb 12;377(9765):557-67. doi: 10.1016/S0140-6736(10)62037-5. Epub 2011 Feb 3.

    PMID: 21295846BACKGROUND

  • Boule NG, Haddad E, Kenny GP, Wells GA, Sigal RJ. Effects of exercise on glycemic control and body mass in type 2 diabetes mellitus: a meta-analysis of controlled clinical trials. JAMA. 2001 Sep 12;286(10):1218-27. doi: 10.1001/jama.286.10.1218.

    PMID: 11559268BACKGROUND

  • Regensteiner JG, Sippel J, McFarling ET, Wolfel EE, Hiatt WR. Effects of non-insulin-dependent diabetes on oxygen consumption during treadmill exercise. Med Sci Sports Exerc. 1995 Jun;27(6):875-81.

    PMID: 7658949BACKGROUND

  • Funai K, Song H, Yin L, Lodhi IJ, Wei X, Yoshino J, Coleman T, Semenkovich CF. Muscle lipogenesis balances insulin sensitivity and strength through calcium signaling. J Clin Invest. 2013 Mar;123(3):1229-40. doi: 10.1172/JCI65726. Epub 2013 Feb 8.

    PMID: 23376793BACKGROUND

  • McGarry JD. What if Minkowski had been ageusic? An alternative angle on diabetes. Science. 1992 Oct 30;258(5083):766-70. doi: 10.1126/science.1439783.

    PMID: 1439783BACKGROUND

  • Kiens B. Skeletal muscle lipid metabolism in exercise and insulin resistance. Physiol Rev. 2006 Jan;86(1):205-43. doi: 10.1152/physrev.00023.2004.

    PMID: 16371598BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

whole blood and frozen tissue

MeSH Terms

Conditions

Metabolic SyndromeGlucose Intolerance

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperglycemia

Results Point of Contact

Title
Samantha Adamson, MD, PhD
Organization
Washington University School of Medicine
sadamson@wustl.edu
314-362-3500

Study Officials

  • Clay F. Semenkovich, M.D.

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

  • Janet B McGill, M.D.

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2014

First Posted

April 24, 2014

Study Start

March 1, 2014

Primary Completion

February 15, 2024

Study Completion

February 15, 2024

Last Updated

October 26, 2024

Results First Posted

October 26, 2024

Record last verified: 2024-08

Locations

US(1)