Clinical trial NCT01234155: Exercise Training and Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Exercise
Diabetes
Obesity
Insulin Sensitivity
Insulin Secretion
Beta-cell Function
Glycemic Control
GIP
GLP-1
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2010-11-04
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess whether 4-months of interval-walking exercise training improves glycemic control in individuals with type 2 diabetes mellitus. The effects of interval-walking training will be compared to continuous-walking exercise in a randomised, controlled trial design. Changes in glycemic control will be examined using oral glucose tolerance tests (OGTT) with stable isotope methodology. In addition, insulin sensitivity and secretion will be examined using glucose clamps combined with glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP).


Eligibility criteria: Inclusion Criteria:

* age 18 to 80
* normal glucose tolerance, impaired glucose tolerance, or type 2 diabetes (as evidenced by use of oral hypoglycemic medication or 2-hour OGTT glucose \> 11.1 mmol/l)

Exclusion Criteria:

* Insulin treatment or type 1 diabetes
* BMI \<19 or \>40
* Physically active
* Undergoing weight-loss/gain
* Pregnancy
* Contraindication to exercise (ECG/CPX)
* Significant cardiovascular disease
* History of renal/hepatic/gastrointestinal/pulmonary disease
* Clotting or bleeding disorders

Primary outcomes:
measure: Glycemic Control
timeFrame: 0 and 4 months
Secondary outcomes:
measure: Beta-cell Function
timeFrame: 0 and 4 months
measure: Body Composition
timeFrame: 0 and 4 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Thomas P Solomon, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, Denmark
name: Kristian Karstoft, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karstoft K, Winding K, Knudsen SH, James NG, Scheel MM, Olesen J, Holst JJ, Pedersen BK, Solomon TP. Mechanisms behind the superior effects of interval vs continuous training on glycaemic control in individuals with type 2 diabetes: a randomised controlled trial. Diabetologia. 2014 Oct;57(10):2081-93. doi: 10.1007/s00125-014-3334-5. Epub 2014 Aug 7.
citation: Solomon TP, Malin SK, Karstoft K, Kashyap SR, Haus JM, Kirwan JP. Pancreatic beta-cell function is a stronger predictor of changes in glycemic control after an aerobic exercise intervention than insulin sensitivity. J Clin Endocrinol Metab. 2013 Oct;98(10):4176-86. doi: 10.1210/jc.2013-2232. Epub 2013 Aug 21.
citation: Solomon TP, Malin SK, Karstoft K, Haus JM, Kirwan JP. The influence of hyperglycemia on the therapeutic effect of exercise on glycemic control in patients with type 2 diabetes mellitus. JAMA Intern Med. 2013 Oct 28;173(19):1834-6. doi: 10.1001/jamainternmed.2013.7783. No abstract available.
citation: Karstoft K, Winding K, Knudsen SH, Nielsen JS, Thomsen C, Pedersen BK, Solomon TP. The effects of free-living interval-walking training on glycemic control, body composition, and physical fitness in type 2 diabetic patients: a randomized, controlled trial. Diabetes Care. 2013 Feb;36(2):228-36. doi: 10.2337/dc12-0658. Epub 2012 Sep 21.