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Impact of Physical Activity on Blood Glucose Stability and Energy Stores in Individuals With Type 1 Diabetes (CARBEX1)

2016년 8월 9일 업데이트: University Hospital Inselspital, Berne

Exercise-related Fuel Metabolism and Glucose Stability in Individuals With Type 1 Diabetes Mellitus

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.

연구 개요

상세 설명

Background

Regular physical activity enhances insulin sensitivity in both healthy subjects and patients with diabetes mellitus. However, while the effects of physical activity on glucose control are undoubtedly beneficial in patients with type 2 diabetes, exercise can cause major disturbances in blood glucose levels in type 1 diabetic individuals. Hypoglycemia is a common complication in patients with T1DM engaging in endurance activities such as running and cycling. So far there are limited strategies suggested to improve exercise-related blood sugar self-management. Current recommendations focus on variation in timing and dosage of insulin administration and adjustments in carbohydrate intake. Since rapid adaptation of insulin dosage may be difficult, alternative strategies to improve exercise-related glucose stability are required. Increasing evidence suggests that intermittent high intensity exercise (IHE), by triggering a counterregulatory hormone response, may counter-balance the risk of exercise-associated hypoglycemia. However, previous studies investigating IHE in T1DM were limited by heterogeneous study populations, comparably short exercise protocols, and deficits in standardization procedures. In addition, a comprehensive assessment of the underlying fuel metabolism has not been performed so far. As a consequence, the results remain controversial and their interpretation as well as applicability are restricted.

A further alternative strategy to maintain stable glycemia during exercise may be deduced from recent studies in non-diabetic individuals suggesting that the combined ingestion of fructose and glucose during exercise provides the liver with an increased amount of gluconeogenic precursors, thereby reducing consumption of endogenous glycogen stores.Moreover, conversion of fructose into glucose and lactate may provide constant and efficient fuel for working muscles. However, studies assessing the impact of fructose ingestion during exercise in patients with T1DM have not been performed so far.

Objective

The investigators aim to assess the impact of two novel non-pharmaceutical and easily feasible approaches on exercise-related blood glucose stability and its underlying exercise-related fuel metabolism in patients with T1DM.

Substudy A will assess the influence on exercise-related glycemia and fuel metabolism of an IHE protocol compared to an iso-energetic continuous exercise (CONT). It will be investigated whether individuals reach more stable blood glucose levels when engaging in IHE compared to CONT.

Substudy B will investigate whether fueling the patients with a mixed oral 1:1 glucose-fructose carbohydrate solution will maintain glucose values within a more stable range when compared to carbohydrate supplementation by glucose alone.

Methods

Blood glucose levels, counterregulatory hormones, metabolites such as lactate and free fatty acids as well as inflammatory biomarkers will be assessed by regular blood samplings. By means of oral and intravenously given stable isotopes (U-13 C glucose and 2H glucose) exercise-related glucose kinetics will be investigated. Exercise-induced glycogen consumption will be measured using magnetic resonance spectroscopy technology. Late glycemic excursions will be recorded by continuous glucose monitoring systems.

In order to validate 13C magnetic resonance spectroscopy (MRS) measurement of hepatic and myocellular glycogen content a pre-study involving 10 patients and an equal number of matched healthy controls will be performed (validation and reproducibility study).

연구 유형

중재적

등록 (실제)

27

단계

  • 해당 없음

연락처 및 위치

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연구 장소

      • Bern, 스위스, 3010
        • Division of Endocrinology, Diabetes and Clinical Nutrition, Bern University Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

남성

설명

Inclusion Criteria:

  • 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

Exclusion Criteria

  • 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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: IHE first, CONT second, CSII and MDI therapy
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: 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
실험적: CONT first, IHE second,CSII and MDI therapy
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: 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
실험적: GLU first, GLUFRU second, CSII and MDI therapy
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.
: 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
실험적: GLU-FRU first, GLU second, CSII therapy
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.
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Amount of exogenous glucose required to maintain glycemia within a range between 7-10mM
기간: 30 minutes (last 30 minutes of 90 min exercise period)
30 minutes (last 30 minutes of 90 min exercise period)

2차 결과 측정

결과 측정
측정값 설명
기간
Exercise - related glycogen consumption
기간: 90 minutes
90 minutes
Glucose kinetics
기간: 180 minutes
Rate of glucose appearance and disappearance
180 minutes
Counterregulatory hormones, metabolites, and inflammatory response
기간: 300 minutes
300 minutes
Spiroergometric parameters
기간: 180 minutes
CO2 and O2 production, RER
180 minutes
Pre- and post-exercise glycemic excursions
기간: 72 h pre-exercise and 72 h post-exercise respectively
72 h pre-exercise and 72 h post-exercise respectively
Heart rate variability
기간: 90 minutes
90 minutes

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Christoph Stettler, Professor, MD, University of Bern

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2014년 2월 1일

기본 완료 (실제)

2016년 7월 1일

연구 완료 (실제)

2016년 7월 1일

연구 등록 날짜

최초 제출

2014년 2월 18일

QC 기준을 충족하는 최초 제출

2014년 2월 19일

처음 게시됨 (추정)

2014년 2월 21일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2016년 8월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 8월 9일

마지막으로 확인됨

2016년 8월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 001/14
  • 320030_149321/1 (기타 식별자: Swiss National Science Foundation (SNF))
  • 191/10 (기타 식별자: Ethics Committee (approval of measurements for healthy controls))

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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