NCT03730168

Brief Summary

Study group included 30 male diabetic patients , they performed circuit weight training exercises for 12 weeks in addition to their medications. However, the control group included 10 patients received medical treatment. Interleukin 6 and tumor necrosis factor alpha were measured before and after the study duration for both groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 13, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 5, 2018

Completed
Last Updated

November 6, 2018

Status Verified

November 1, 2018

Enrollment Period

3 months

First QC Date

October 15, 2018

Last Update Submit

November 5, 2018

Conditions

Keywords

Diabetes mellitus.Inflammatory markersCircuit weight training

Outcome Measures

Primary Outcomes (1)

  • concentration of serum intereukin6

    Laboratory investigation to assess inflammatory marker response to circuit weight training program in male diabetic patients. training was three times weekly for 12 weeks.

    change from baseline and after 12 weeks

Secondary Outcomes (1)

  • concentration of serum tumour necrosis factor

    change from baseine and after 12 weeks

Study Arms (1)

study group and control group

EXPERIMENTAL

Two groups; study group included 30 diabetic male patients who where trained by circuit weight training program in the form of sets of resistance exercises (in the form of dumbbells and sand bags) for the muscles of lower limb and upper limb .The training sessions were performed 3 days per week for a period of 12 weeks. All patient were on their prescribed routine medications . The control group were on there prescribed medications only .

Other: circuit weight training program

Interventions

30 male diabetic patients performed circuit weight training for 12 weeks

Also known as: Resisted exercises using free weights
study group and control group

Eligibility Criteria

Age45 Years - 55 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The selected subjects are diagnosed clinically and laboratory with diabetes mellitus type 2 by physicians.
  • All patients have moderate hyperglycemia tested by fasting plasma glucose and a two hours plasma glucose ≥ 200 mg/dl (11.1mmol/l) during an oral glucose tolerance test (OGTT).
  • The onset of the disease will be more than 10 years.
  • All patients follow an oral hypoglycemicdrug.

You may not qualify if:

  • Hepatic diseases.
  • Cancer patients.
  • Renal failure patients.
  • Orthopedic problems or fractures of extremities.
  • Neurological problems.
  • Severely hypertensive patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Giza, Cairo Governorate, 12613, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

October 15, 2018

First Posted

November 5, 2018

Study Start

May 13, 2018

Primary Completion

August 20, 2018

Study Completion

August 20, 2018

Last Updated

November 6, 2018

Record last verified: 2018-11

Locations