NCT06223490

Brief Summary

Diabetes mellitus (DM) is a complex chronic illness associated with a state of high blood glucose level, or hyperglycemia, occurring from deficiencies in insulin secretion, action, or both. Diabetes mellitus is the name given to a wide spectrum group of disorders characterized by raised plasma glucose.Type 1 diabetes is characterized by an absolute insulin deficiency due to autoimmune destruction of insulin producing beta cells in the pancreas. most adults with diabetes have type 2, characterized by a relative insulin secretory defect, and target tissue resistance to the effects of insulin.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2024

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

January 25, 2024

Status Verified

January 1, 2024

Enrollment Period

3 months

First QC Date

January 6, 2024

Last Update Submit

January 23, 2024

Conditions

Keywords

TII DMObese FemalesCryolipolysis

Outcome Measures

Primary Outcomes (1)

  • Skin fold thickness and estimation of total body fat

    Estimation of body fat for all cases and is done by measuring these parameters : weight in kilograms, height in meters as weight and height will be combined to report BMI in kg/m\^2.

    3 months

Study Arms (2)

Cryolipolysis Group

ACTIVE COMPARATOR

About 30 obese females with type 2 diabetes and will face cryolypolysis in addition to exercise therapy treatment

Procedure: Cryolipolysis

Group of Exercise

ACTIVE COMPARATOR

About 30 obese females with type 2 diabetes and will face exercise therapy treatment only.

Procedure: Cryolipolysis

Interventions

CryolipolysisPROCEDURE

To investigate the Effect of Cryolipolysis On insulin resistance and In adult type 2 female patients.

Also known as: Exercise therapy
Cryolipolysis GroupGroup of Exercise

Eligibility Criteria

Age35 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with incidence of diabetes 5 years ago.
  • Patient fasting glucose level is more than 140 mg/dL.
  • Age will be ranged from 35 to 45 years
  • Body mass index between 25 and 30.
  • All patients are medically controlled
  • All patients have the same medical care.
  • All patients will receive a good explanation of treatment procedures.

You may not qualify if:

  • Patients dependent on insulin.
  • Renal failure.
  • Myocardial infractions.
  • Cardiovascular problems.
  • Neurological disorders.
  • Patients with orthopedic problems (e.g mal or incomplete union of fracture, ankle sprains.
  • Abdominal hernia
  • Skin disease
  • Unstable cases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Exercise Therapy

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Akram Abd El Aziz, Assist.Prof

    Cairo University

    STUDY CHAIR

Central Study Contacts

NOURA RAMADAN, MSC

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Physical therapy

Study Record Dates

First Submitted

January 6, 2024

First Posted

January 25, 2024

Study Start

November 1, 2023

Primary Completion

January 20, 2024

Study Completion

January 30, 2024

Last Updated

January 25, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations