- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07365878
Effect of Dry Needling on Insulin Resistance in Obese Post Menopausal Women (Dry needle)
Effect of Dry Needling on Insulin Resistance in Obese Post- Menopausal Women
Study Overview
Status
Intervention / Treatment
Detailed Description
Insulin resistance and abdominal obesity have a negative impact on quality of life of postmenopausal women. Obesity and, more specifically, the level of intra-abdominal fat, are positively associated with cardiovascular disease and cardiovascular disease risk factors such as increased plasma lipids and lipoproteins, hyperinsulinemia, and insulin resistance. This study has shown associations among menopause, body fat, and body fat distribution, suggesting that increased abdominal fat distribution could partially mediate the increased cardiovascular disease risk of postmenopausal women .
Abdominal obesity can reflect excess of visceral fat tissue or subcutaneous or both. Visceral fat contributes to the pathogenesis of glucose intolerance and insulin resistance. Insulin resistance is an impaired condition of glucose absorption that induced by insulin .It represents a significant medical and socioeconomic issue impacting women's health and quality of life. So there is clinical experience and documentation for the effectiveness of Dry Needling in the treatment of insulin resistance in obese post-menopausal women.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Cairo, Egypt
- Shymaa Mohammed
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• All participants post-menopausal from at least 3 years.
- All participants' ages will be ranged from 48-60 years old.
- All participants BMI will exceed 25-30 kg/m2.
- All participants waist hip ratio will be equal or more than 0, 90.
Exclusion Criteria:
• Surgical liposuction within the last 12 months.
- Untreated hypo- or hyperthyroidism.
- Uncontrolled liver, kidney or cardiovascular disease or diabetes.
- Implanted pacemaker or metal implant.
- History of thrombophlebitis, any hematological disease.
- No past or present neurological and musculoskeletal disorders that will have affected health condition.
- No smoking and drinking habits.
- No psychological problems.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Dry Needle
26 patients who were treated with Dry Needling (three times /week/4 months), abdominal exercises, and medical standard care for insulin resistance.
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Dry Needle has been used to treat obesity.
Clinical research has found that it is particularly effective for abdominal fat loss.Dry needling in the abdominal region requires an in-depth understanding of the underlying anatomy due to significant safety risks.
To reduce belly fat, combine core-strengthening exercises like planks, bicycle crunches, and leg raises with overall fat-burning cardio (walking, running) and a healthy diet
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Other: abdominal exercises and medical standard care for insulin resistance.
While Group (B), 26 patients treated with abdominal exercises and medical standard care for insulin resistance.
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To reduce belly fat, combine core-strengthening exercises like planks, bicycle crunches, and leg raises with overall fat-burning cardio (walking, running) and a healthy diet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HOMA-IR
Time Frame: 4 months
|
Outcome measures, HOMA-IR (Homeostasis Model Assessment) will be used to assess insulin resistance.
HOMA-IR is a model of interactions between glucose and insulin dynamics that is then used to predict fasting steady-state glucose and insulin concentrations for a wide range of possible combinations of insulin resistance and β-cell function.
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4 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ultrasound
Time Frame: 4 months
|
Abdominal fat thickness will be assessed by ultrasound (Aplio 500-model TUS-A500, fundamentals (2B77-004EN*M)
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4 months
|
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BMI by kg/m2
Time Frame: 4 months
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weight and height will be combined to report BMI in kg/m^2
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4 months
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waist circumferences by tape
Time Frame: 4 months
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4 months
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The surface under the cumulative ranking curve (SUCRA)
Time Frame: 4 months
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The surface under the cumulative ranking curve (SUCRA) was used to rank and compare the effects of different types of exercise.
SUCRA values range from 0 to 100, where 100 indicates the best treatment with no uncertainty and 0 indicates the worst treatment with no uncertainty.
Thus, higher SUCRA values indicated the better effects of an exercise intervention prior to and after four-month treatment duration for both groups.
|
4 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shymaa Mohammed, out patient clinic ,faculty of physical therapy ,Cairo university ,Cairo,Egypt
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- P.T.REC/012/006055
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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