Effect of Cryolipolysis on Insulin Resistance

Cryotherapy Effect Clinical Trial

Official title:

Effect of Cryolipolysis on Insulin Resistance in Type 2 Diabetic Females With Abdominal Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06223490
• Other study ID #: Noura Fahmy
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: January 30, 2024

Study information

• Verified date: January 2024
• Source: Cairo University
• Contact: NOURA RAMADAN, MSC
• Phone: +201158577826
• Email: drnourramadaan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Diabetes is one of the most important health problems and chronic metabolic diseases requiring critical care.The number of people with diabetes has risen from 108 million in 1980 to 422 million in 2014.

Type 2 diabetes mellitus is a common and increasingly prevalent disease and is thus a major public health concern worldwide. The International Diabetes Federation estimates that there are approximately 387 million people diagnosed with diabetes across the globe.

The clinical diagnosis of diabetes is reliant on either one of the four plasma glucose (PG) criteria: elevated (i) fasting plasma glucose (FPG) (>126 mg/dL), (ii) 2 h PG during a 75-g oral glucose tolerance test (OGTT) (>200 mg/dL), (iii) random PG (>200 mg/dL) with classic signs and symptoms of hyperglycemia, or (iv) hemoglobin A1C level >6.5%.

The principal tissues affected by insulin resistance are liver, muscle and fat. In the liver this impaired insulin related inhibition of hepatic gluconeogenesis results in increased hepatic glucose output, exacerbating hyperglycemia.

In muscle, reduced transport of carbohydrates into muscle combined with lipid deposition in muscle cells leads toimpaired exercise ability and lowered threshold for tiredness with exercise. In fat tissue, there is impaired insulin-mediated inhibition of hormone dependent lipase, with breakdown of lipids to free fatty acids and glycerol, contributing to the dyslipidemia. With the rise in diabetes prevalence, researchers have increasingly investigated treatments intended to improve health and quality of life. People are much more likely to achieve metabolic control when they adhere to recommended diets, medications and exercise behaviors.

Cryolipolysis (CoolSculpting, Zeltiq, Pleasanton, CA) is a novel method of selective removal of fat with cooling. This technique is basedon the concept that fat cells are more sensitive to cold than the surrounding tissue. Prior studies and observations have demonstrated that cold exposure can induce selective damage to the subcutaneous fat via induction of panniculitis, resulting in reduction in the superficial fat layer of the skin

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 30, 2024
• Est. primary completion date: January 20, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cryotherapy Effect
• Diabetes Mellitus, Type 2
• Insulin Resistance
• Type 2 Diabetes Mellitus in Obese

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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