The acute effects of different types of exercise on glycemic rpofiles in people with diabetes; A single-center prospective study

JRCT ID: jRCT1030240040

Registered date:19/04/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Diabetes mellitus
• Date of first enrollment: 19/04/2024
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Aerobic and resistance exercise

Outcome(s)

• Primary Outcome: Difference in time in range (TIR; 70-180 mg/dL) by continuous glucose monitoring (CGM) in 6 hours after lunch intake between 2 type of exercises

Secondary Outcome

(i) Difference in time below range (TBR; <70 mg/dL) by CGM for 6 hours after lunch intake
(ii) Difference in time above range (TAR; >180 mg/dL) by CGM for 6 hours after lunch intake
(iii) Difference in time in tight range (TITR; 70-140 mg/dL) by CGM for 6 hours after lunch intake
(iv) Difference in mean sensor glucose level by CGM at 6 hours after lunch intake
5) Difference in %CV (coefficient of variation) of sensor glucose values by CGM for 6 hours after lunch intake
(vi) Comparison of the above endpoints by differences in clinical indicators such as gender, age, diabetes type, and muscle mass
7) Differences in TIR, TBR, TAR, TITR, mean sensor glucose value, and %CV by the order of each exercise.
(viii) Evaluation of safety with respect to events such as hypoglycemia, including TBR, and falls with each exercise

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable

Include criteria

(1) People with diabetes over 18 years old who are using professional continuous glucose monitoring (CGM) for glycemic control during hospitalization.
(2) Any gender and any type of diabetes
(3) Perticipants who are independent in ADL (including stair climbing)

Exclude criteria

(1) The following cases in which exercise therapy should be prohibited or limited in diabetes patients
1) Extremely poor diabetes control (fasting blood glucose >250 mg/dL, urine ketones moderately positive or higher)
2) Fresh fundus hemorrhage due to proliferative diabetic retinopathy
3) Patients with renal failure (serum Cr: >= 2.5 mg/dL in men, >= 2.0 mg/dL in women)
4) Patients with ischemic heart disease or cardiopulmonary dysfunction
5) Patients with bone or joint disease
6) Patients with acute infectious complications
7) Diabetic foot gangrene
8) Severe diabetic autonomic neuropathy
9) Pregnancy or possible pregnancy
(2) Patient is using an implantable medical device (e.g., pacemaker)
(3) Patients with active malignant tumors
(4) Those who cannot give consent for this study
(5) Those who are judged to be inappropriate to participate in this clinical research by the principal investigator, research coordinator, or physical therapist.

Related Information

• Primary Sponsor: Hayashi Akinori