Exercise Training and Type 2 Diabetes

NCT01234155 | Completed

• 1 other identifier: H-1-2010-027
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetes Mellitus, Type 2

Keywords

Exercise; Diabetes; Obesity; Insulin Sensitivity; Insulin Secretion; Beta-cell Function; Glycemic Control; GIP; GLP-1

Outcome Measures

Primary Outcomes (1)

• Glycemic Control

  Fasting glucose, two-hour glucose during OGTT, and hemoglobin A1c will be measured.

  0 and 4 months

Secondary Outcomes (2)

• Beta-cell Function

  0 and 4 months

• Body Composition

  0 and 4 months

Study Arms (3)

Control

NO INTERVENTION

Exercise - Continuous Walking

EXPERIMENTAL

Behavioral: Exercise - Continuous Walking

Exercise - Interval Walking

EXPERIMENTAL

Behavioral: Exercise Training - Interval Walking

Interventions

Exercise Training - Interval Walking BEHAVIORAL

Duration: 4 months. Exercise training sessions will be performed 3-5 days/week. Sessions will consist of walking for 3 minutes at 70% VO2max followed by 3 minutes at 40% VO2max for up to 60 minutes/day.

Exercise - Interval Walking

Exercise - Continuous Walking BEHAVIORAL

Duration: 4 months. Exercise training sessions will be performed 3-5 days/week and will consist of walking for up to 60 minutes/day at 55% VO2max.

Exercise - Continuous Walking

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (4)

• 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.

  PMID: 25099941 DERIVED

• 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.

  PMID: 23966244 DERIVED

• 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.

  PMID: 23817567 DERIVED

• 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.

  PMID: 23002086 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity; Diabetes Mellitus; Obesity; Insulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism

Study Officials

• Thomas P Solomon, Ph.D.

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

• Kristian Karstoft, M.D.

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Group Leader

Study Record Dates

• First Submitted: November 1, 2010
• First Posted: November 4, 2010
• Study Start: August 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2014
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

DK (1)