Effects of Aerobic Training on Pancreatic Fat and Cognitive Function in T2DM Patients

NCT04489966 | Completed

• 1 other identifier: 2019LWKY009
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study was to evaluate the difference in cognitive function and brain functional structure between exercise group and control group by performing regular one-year moderate-intensity aerobic training in type 2 diabetes mellitus (T2DM) with normal cognitive function. The secondary aim of this study was to explore the effects of six-month regular moderate-intensity aerobic training on pancreatic fat content, metabolic index of glucose and lipid, as well as cardiovascular risks in patients type 2 diabetes mellitus.

Conditions

Type 2 Diabetes Mellitus

Keywords

aerobic training; type 2 diabetes mellitus; pancreatic fat content; cognitive function; hippocampal volume

Outcome Measures

Primary Outcomes (4)

• Cognitive function scale(1)

  Mini-mental State Examination(MMSE) includes five aspects: orientation, memory, attention and calculation, recall and language ability, with a total score of 30.The scoring standard is: 27-30 is normal;\< 27 was divided into cognitive impairment;Mild cognitive impairment ≥21 and \< 27 points;Moderate cognitive impairment 10-20;Severe cognitive impairment ≤9, the higher the score, the better the cognitive function.

  12 months

• Cognitive function scale(2)

  The Montreal Cognitive Assessment Scale (MoCA) includes eight aspects: visuospatial and executive function, nomenclature, memory, attention, language, abstraction, delayed recall, and orientation for a total of 30 points.The score criteria are as follows: ≥26 is considered as normal cognitive function; \< 26 is considered as cognitive dysfunction. If the number of years of education ≤12 years, the score is added 1 point to correct cultural influence. The lower the score, the worse the cognitive function.

  12 months

• Brain functional structure---Hippocampal volume

  Hippocampal volume measurement by the same operation, all patients using 3D brain volume sequence (3D - BRAVO) image data acquisition of high resolution T1W1 brain structure, specific scanning parameters is as follows: repetition time (TR) = 9.5 ms, Time of Echo(TE) = 3.9 ms, Flip angle (FA) = 12 °, matrix=320 x 320, scanned area (FOV) = 22 x 22 cm, depth of stratum=1.5mm, interlamellar spacing =1.5mm.

  12 months

• Abdominal fat Abdominal fat

  Pancreatic fat content（PFC,%）

  6 months

Secondary Outcomes (11)

• Glycemic control(1)

  12 months

• Glycemic control(2)

  Time Frame: 12 months

• Hemoglobin A1c

  12 months

• HOMA2-IR and HOMA2-β

  12 months

• Blood lipids

  12 months

Study Arms (4)

Aerobic training group

EXPERIMENTAL

The aerobic training group was performed 3 times/week for 60 minutes/session(including 5 minutes of warm-up, 50 minutes aerobic rhythmic exercise and 5 minutes to relax) for moderate(60 to 70% of participants' HRmax) aerobic rhythmic exercise. All patients received an open class, relate to diabetes health education. The intervention lasted for 6 months.

Behavioral: Aerobic training

Control group

NO INTERVENTION

Patients in control group remained the original lifestyle unchanged. All patients received an open class, relate to diabetes health education.

Intervention group

EXPERIMENTAL

The intervention was aerobic rhythmic exercise, with intensive training under the guidance and supervision of a professional.The aerobic training program required participants to exercise 3 days/week for 60 minutes/session (including 5-10 minutes of warm-up and 5-10 minutes flexibility exercises). Participants were educated on aerobic exercises (aerobic dancing) with music.The intervention lasted for one year.

Behavioral: Aerobic training

Compared group

NO INTERVENTION

The control group was instructed to maintain their usual habits and received no structured exercise intervention. But the form, frequency and time of movement of each participant must be recorded.Participants receive an open diabetes health education class once a month, which is taught by a specially trained diabetes nurse.

Interventions

Aerobic training BEHAVIORAL

The intervention was aerobic rhythmic training under the guidance and supervision of a professional. The aerobic training program required participants to exercise 3 days/week for 60 minutes/session (including 5-10 minutes of warm-up and 50 minutes aerobic training and 5-10 minutes to relax). All patients received an open class, relate to diabetes health education．

Aerobic training group; Intervention group

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed of T2DM based on the 1999 diagnostic criteria of the WHO;
• Had normal muscle strength; 3.18.5≤BMI≤35kg/m2;
• Had normal cognitive function ( MMSE ≥27 points, MoCA ≥26 points) ; 5.Primary school education or above ( Participants were able to fill in the scale) ; 6.Aged 60-75 years; 7.Had ≥5 years duration of T2DM; 8.Had no evidence of hearing or visual impairment and communication difficulties; 9.Were willing to participate in the study and signed informed consent voluntarily.

You may not qualify if:

• With severe acute complications of diabetes;
• Serious heart, liver and kidney dysfunction, and cardiovascular and cerebrovascular diseases, such as cerebral infarction, cerebral hemorrhage, etc.;
• Pregnant and lactating women;
• Sleep disorders (PSQI \>7 points);
• Had a family history of dementia;
• Alcohol dependence and oral medications that affect cognitive function (such as antipsychotic drugs, sedative hypnotics, etc.);
• Contraindications for MRI, such as metal implant in the body.

Sponsors & Collaborators

• Nanjing University of Traditional Chinese Medicine: lead

Study Sites (1)

Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine

Nanjing, Jiangsu, 210028, China

Location

Related Publications (2)

• Alberti KG, Zimmet PZ. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation. Diabet Med. 1998 Jul;15(7):539-53. doi: 10.1002/(SICI)1096-9136(199807)15:73.0.CO;2-S.

  PMID: 9686693 RESULT

• Wang Y, Wang L, Yan J, Yuan X, Lou QQ. Aerobic Training Increases Hippocampal Volume and Protects Cognitive Function for Type 2 Diabetes Patients with Normal Cognition. Exp Clin Endocrinol Diabetes. 2023 Nov;131(11):605-614. doi: 10.1055/a-2105-0799. Epub 2023 Jun 2.

  PMID: 37268011 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Qingqing Lou, PhD

  Nanjing University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Health Education Department

Study Record Dates

• First Submitted: July 17, 2020
• First Posted: July 28, 2020
• Study Start: December 1, 2018
• Primary Completion: January 1, 2020
• Study Completion: March 20, 2020
• Last Updated: January 5, 2021

Record last verified: 2021-01

Locations

CN (1)