Impact of Physical Activity on Blood Glucose Stability and Energy Stores in Individuals With Type 1 Diabetes

NCT02068638 | Completed

• 3 other identifiers: 001/14320030_149321/1191/10
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Whereas physical activity clearly results in improvements in glycemic control in type 2 diabetes, in individuals with type 1 diabetes (T1DM) the impact of exercise on blood sugar control is more complex. In type 1 diabetes T1DM the inability to reduce exogenous insulin levels during exercise is a key factor that contributes to an increased risk of exercise-induced hypoglycemia. Since rapid adaptation of insulin dosage may be especially difficult in patients on a multiple daily injection regimen, alternative strategies are required to improve exercise-associated glucose stability. There is increasing evidence that the combination of steady state continuous low to moderate intensity exercise with short bursts of high intensity exertion (eg in the form of sprints) is an effective, well tolerated, novel strategy to prevent exercise-related hypoglycemia. A further promising option to stabilize blood sugar levels during and after exercise may be the ingestion of fructose in addition to glucose in form of a sport drink.

Conditions

Type 1 Diabetes Mellitus; Exercise; Hypoglycemia; Carbohydrate Metabolism

Keywords

exercise; isotope labeling, stable; spectroscopy, magnetic resonance; monitoring, home blood glucose; hormones

Outcome Measures

Primary Outcomes (1)

• Amount of exogenous glucose required to maintain glycemia within a range between 7-10mM

  30 minutes (last 30 minutes of 90 min exercise period)

Secondary Outcomes (6)

• Exercise - related glycogen consumption

  90 minutes

• Glucose kinetics

  180 minutes

• Counterregulatory hormones, metabolites, and inflammatory response

  300 minutes

• Spiroergometric parameters

  180 minutes

• Pre- and post-exercise glycemic excursions

  72 h pre-exercise and 72 h post-exercise respectively

Study Arms (4)

IHE first, CONT second, CSII and MDI therapy

EXPERIMENTAL

IHE: intermittent high intensity exercise: integration of 10 s maximal sprints every 10 minutes in a continuous low to moderate intensity exercise of 90 minutes CONT (occurring after a washout period of 2-8 weeks): continuous moderate intensity exercise of 90 minutes

Procedure: IHE first, CONT second

CONT first, IHE second,CSII and MDI therapy

EXPERIMENTAL

CONT: continuous moderate intensity exercise of 90 minutes. IHE (occurring after a washout period of 2-8 weeks): intermittent high intensity exercise: integration of 10 s maximal sprints every 10 minutes in a continuous low to moderate intensity exercise of 90 minutes

Procedure: CONT first, IHE second

GLU first, GLUFRU second, CSII and MDI therapy

EXPERIMENTAL

GLU: ingestion of a 6% carbohydrate solution (consisting of 100 g glucose dissolved in 1000 ml tap water) over a continuous moderate exercise of 90 minutes. GLU FRU (occurring after a washout period of 2-8 weeks): ingestion of a 20% carbohydrate solution (consisting of 100 g glucose + 100 g fructose dissolved in 1000 ml tap water) over a continuous moderate exercise of 90 minutes. CSII = continuous subcutaneous insulin infusion. MDI=multiple daily injections.

Procedure: GLU first, GLU-FRU second

GLU-FRU first, GLU second, CSII therapy

EXPERIMENTAL

GLU-FRU : ingestion of a 20% carbohydrate solution (consisting of 100 g glucose + 100 g fructose dissolved in 1000 ml tap water) over a continuous moderate exercise of 90 minutes. GLU (occurring after a washout period of 2-8 weeks): ingestion of a 10% carbohydrate solution (consisting of 100 g glucose dissolved in 1000 ml tap water) over a continuous moderate exercise of 90 minutes. CSII = continuous subcutaneous insulin infusion. MDI=multiple daily injections.

Procedure: GLU-FRU first, GLU second

Interventions

IHE first, CONT second PROCEDURE

IHE: intermittent high intensity exercise: integration of 10 s maximal sprints every 10 minutes in a continuous low to moderate intensity exercise of 90 minutes. CONT (occurring after a washout period of 2-8 weeks): continuous moderate intensity exercise of 90 minutes

IHE first, CONT second, CSII and MDI therapy

CONT first, IHE second PROCEDURE

CONT: continuous moderate intensity exercise of 90 minutes. IHE (occurring after a washout period of 2-8 weeks): intermittent high intensity exercise: integration of 10 s maximal sprints every 10 minutes in a continuous low to moderate intensity exercise of 90 minutes

CONT first, IHE second,CSII and MDI therapy

GLU first, GLU-FRU second PROCEDURE

: ingestion of a 6% carbohydrate solution (consisting of 90 g glucose dissolved in 1500 ml tap water) over a continuous moderate exercise of 90 minutes. GLU FRU (occurring after a washout period of 2-8 weeks): ingestion of a 12% carbohydrate solution (consisting of 90 g glucose + 90 g fructose dissolved in 1500 ml tap water) over a continuous moderate exercise of 90 minutes

GLU first, GLUFRU second, CSII and MDI therapy

GLU-FRU first, GLU second PROCEDURE

GLU-FRU : ingestion of a 12% carbohydrate solution (consisting of 90 g glucose + 90 g fructose dissolved in 1500 ml tap water) over a continuous moderate exercise of 90 minutes. GLU (occurring after a washout period of 2-8 weeks): : ingestion of a 6% carbohydrate solution (consisting of 90 g glucose dissolved in 1500 ml tap water) over a continuous moderate exercise of 90 minutes.

GLU-FRU first, GLU second, CSII therapy

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• Aged 18 to 35 years
• Diabetes mellitus duration for at least 5 years
• No change in insulin regimen for at least 3 months prior to the study
• Under acceptable to good metabolic control
• Normal insulin sensitivity
• Regular physical activity
• BMI in the range of 18-25 kg/m2
• Written informed consent

You may not qualify if:

• Diabetes-related complications (macro and microvascular)
• Anemia (hemoglobin concentration \<130g/l)
• Abnormal thyroid function
• Dyslipidemia
• Major depression, psychosis and other severe personality disorders, claustrophobia
• Active neoplasia
• Contraindications to exposure to a 3 T magnetic field
• Abnormal liver or renal function
• Smoking, drug abuse, or daily alcohol consumption \>60g
• Participation in another study
• Medication other than insulin

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University of Bern: collaborator
• University of Lausanne: collaborator

Study Sites (1)

Division of Endocrinology, Diabetes and Clinical Nutrition, Bern University Hospital

Bern, 3010, Switzerland

Location

Related Publications (11)

• Stettler C, Jenni S, Allemann S, Steiner R, Hoppeler H, Trepp R, Christ ER, Zwahlen M, Diem P. Exercise capacity in subjects with type 1 diabetes mellitus in eu- and hyperglycaemia. Diabetes Metab Res Rev. 2006 Jul-Aug;22(4):300-6. doi: 10.1002/dmrr.608.

  PMID: 16302286 RESULT

• Jenni S, Oetliker C, Allemann S, Ith M, Tappy L, Wuerth S, Egger A, Boesch C, Schneiter P, Diem P, Christ E, Stettler C. Fuel metabolism during exercise in euglycaemia and hyperglycaemia in patients with type 1 diabetes mellitus--a prospective single-blinded randomised crossover trial. Diabetologia. 2008 Aug;51(8):1457-65. doi: 10.1007/s00125-008-1045-5. Epub 2008 May 30.

  PMID: 18512043 RESULT

• Bussau VA, Ferreira LD, Jones TW, Fournier PA. The 10-s maximal sprint: a novel approach to counter an exercise-mediated fall in glycemia in individuals with type 1 diabetes. Diabetes Care. 2006 Mar;29(3):601-6. doi: 10.2337/diacare.29.03.06.dc05-1764.

  PMID: 16505513 RESULT

• Bussau VA, Ferreira LD, Jones TW, Fournier PA. A 10-s sprint performed prior to moderate-intensity exercise prevents early post-exercise fall in glycaemia in individuals with type 1 diabetes. Diabetologia. 2007 Sep;50(9):1815-1818. doi: 10.1007/s00125-007-0727-8. Epub 2007 Jun 22.

  PMID: 17583795 RESULT

• Guelfi KJ, Jones TW, Fournier PA. The decline in blood glucose levels is less with intermittent high-intensity compared with moderate exercise in individuals with type 1 diabetes. Diabetes Care. 2005 Jun;28(6):1289-94. doi: 10.2337/diacare.28.6.1289.

  PMID: 15920041 RESULT

• Guelfi KJ, Ratnam N, Smythe GA, Jones TW, Fournier PA. Effect of intermittent high-intensity compared with continuous moderate exercise on glucose production and utilization in individuals with type 1 diabetes. Am J Physiol Endocrinol Metab. 2007 Mar;292(3):E865-70. doi: 10.1152/ajpendo.00533.2006.

  PMID: 17339500 RESULT

• Iscoe KE, Riddell MC. Continuous moderate-intensity exercise with or without intermittent high-intensity work: effects on acute and late glycaemia in athletes with Type 1 diabetes mellitus. Diabet Med. 2011 Jul;28(7):824-32. doi: 10.1111/j.1464-5491.2011.03274.x.

  PMID: 21388440 RESULT

• Lecoultre V, Benoit R, Carrel G, Schutz Y, Millet GP, Tappy L, Schneiter P. Fructose and glucose co-ingestion during prolonged exercise increases lactate and glucose fluxes and oxidation compared with an equimolar intake of glucose. Am J Clin Nutr. 2010 Nov;92(5):1071-9. doi: 10.3945/ajcn.2010.29566. Epub 2010 Sep 8.

  PMID: 20826630 RESULT

• Eckstein ML, Farinha JB, McCarthy O, West DJ, Yardley JE, Bally L, Zueger T, Stettler C, Boff W, Reischak-Oliveira A, Riddell MC, Zaharieva DP, Pieber TR, Muller A, Birnbaumer P, Aziz F, Brugnara L, Haahr H, Zijlstra E, Heise T, Sourij H, Roden M, Hofmann P, Bracken RM, Pesta D, Moser O. Differences in Physiological Responses to Cardiopulmonary Exercise Testing in Adults With and Without Type 1 Diabetes: A Pooled Analysis. Diabetes Care. 2021 Jan;44(1):240-247. doi: 10.2337/dc20-1496. Epub 2020 Nov 12.

  PMID: 33184152 DERIVED

• Bally L, Zueger T, Buehler T, Dokumaci AS, Speck C, Pasi N, Ciller C, Paganini D, Feller K, Loher H, Rosset R, Wilhelm M, Tappy L, Boesch C, Stettler C. Metabolic and hormonal response to intermittent high-intensity and continuous moderate intensity exercise in individuals with type 1 diabetes: a randomised crossover study. Diabetologia. 2016 Apr;59(4):776-84. doi: 10.1007/s00125-015-3854-7. Epub 2016 Jan 6.

  PMID: 26739816 DERIVED

• Bally L, Zueger T, Pasi N, Carlos C, Paganini D, Stettler C. Accuracy of continuous glucose monitoring during differing exercise conditions. Diabetes Res Clin Pract. 2016 Feb;112:1-5. doi: 10.1016/j.diabres.2015.11.012. Epub 2015 Dec 19.

  PMID: 26739116 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Motor Activity; Hypoglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Officials

• Christoph Stettler, Professor, MD

  University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2014
• First Posted: February 21, 2014
• Study Start: February 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 10, 2016

Record last verified: 2016-08

Locations

CH (1)