NCT02645448

Brief Summary

The aim of this study was to investigate and correlate the glucose responses and VFC 24 hours after resistance exercise (RE) sessions at different intensities in women with type 2 diabetes (DM-2). Twelve women with DM-2 were invited to perform by one week in randomized order, two weeks interventions with experimental sessions: Session Control (CONT) without conducting RE, RE session (40% or 80% of one maximum repetition - 1RM) on day 2 and day 3 was observed the effect of the length of RE session by 11h. After that, initiated the experimental sessions, where after each of the analysis of glucose 24h by continuous monitoring system of glucose was performed, considering breakfast, lunch, dinner and sleep, and analysis performed of the RR series by a period of 48h. During control sessions, the subjects were seated comfortably for 40min and RE sessions, 40%1RM and 80%1RM, were performed in medium circuit 3 sets with 16 and 8 replications and recovery range between 60 exercises and 90seg , respectively, and between the circuits 120sec. It was observed that the concentration of glucose in the period of 24h after the session has been reduced to 40% 1RM vs. CONT and 80%1RM. Hyperglycemia was prevalent in the period 34h of the sessions CONT and 80%1RM, respectively , being different from the session 40%1RM. In postprandial times, shorter hyperglycemia was found in the session to 40% 1RM vs. CONT and 80% 1RM after breakfast, lunch and dinner. At the time of sleep, less time in hyperglycemia was found between sessions of 40% 1RM vs. 80% 1RM. Significant correlations (p \<0.01) were found between glucose 24h with cardiac autonomic RRi variables, HF, LF and reason LF:HF.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Nov 2014

Shorter than P25 for not_applicable diabetes-mellitus

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 1, 2016

Completed
Last Updated

January 1, 2016

Status Verified

December 1, 2015

Enrollment Period

9 months

First QC Date

December 12, 2015

Last Update Submit

December 30, 2015

Conditions

Keywords

Resistance ExerciseDiabetes MellitusHeart Rate Variability

Outcome Measures

Primary Outcomes (1)

  • Concentration of glucose and hyperglycemia prevalence

    Acute bout of resistance exercise at 40% 1RM (low intensity) reduced glucose concentrations and the prevalence of hyperglycemia in 73.1 ± 37.7% and 68.4 ± 51.1% compared to the sessions CONT40% and resistance exercise 80% 1RM (high intensity) respectively in 24h from each session.

    24 hours

Secondary Outcomes (2)

  • Heart Rate Variability

    24 hours

  • Correlation between heart rate variability and glucose 24 hours

    24 hours

Study Arms (2)

Resistance Exercise Low intensity

OTHER

Day 1 (Control Session) Day 2 (Resistance Exercise) Day 3 (Duration of effect)

Other: Resistance Exercise

Resistance Exercise High intensity

OTHER

Day 1 (Control Session) Day 2 (Resistance Exercise) Day 3 (Duration of effect)

Other: Resistance Exercise

Interventions

Control Session Resistance exercise at different intensities (40%1RM or 80%1RM) Duration of effect

Resistance Exercise High intensityResistance Exercise Low intensity

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Being female, diagnosed with type 2 diabetes (DM-2) and be clinically stable, and be aged between 40 and 60 years.

You may not qualify if:

  • Make use of exogenous insulin
  • Have morbid obesity (BMI\> 40 kg / m2)
  • Provide uncompensated glucose and abnormalities in the electrocardiogram (ECG) at rest with suggestion of cardiac ischemia from above or below unevenness in the ST segment\> 2mm or reversal in T wave
  • Presenting heart disease
  • Proliferative diabetic retinopathy
  • Severe autonomic neuropathy
  • Any limb amputation
  • Uncontrolled hypertension (systolic\> 160 mmHg and / or diastolic BP\> 100 mmHg)
  • Diabetic nephropathy (albuminuria ≥ 14mg / L or\> 30mg / 24h) chronic renal failure (SBD, 2014; ADA, 2014)
  • Osteo-myo-articular problems that limited the exercises and being a smoker.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes MellitusAutonomic Nervous System Diseases

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Loumaíra Carvalho da Cruz

    Universidade Federal do vale do São Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 12, 2015

First Posted

January 1, 2016

Study Start

November 1, 2014

Primary Completion

August 1, 2015

Study Completion

September 1, 2015

Last Updated

January 1, 2016

Record last verified: 2015-12

Data Sharing

IPD Sharing
Will not share