- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07688824
The Effect of SPU on Hormonal and Cardiometabolic Factors
Study Overview
Status
Intervention / Treatment
Detailed Description
The primary characteristic of hypothyroidism is sluggish metabolism, which is usually associated with abnormal weight gain, lethargy, constipation, heavy menstrual bleeding, hair loss, cold intolerance, and bradycardia. Importantly, these symptoms have been linked to reduced glucose tolerance and insulin sensitivity though glucose turnover and plasma insulin concentration are elevated. These metabolic changes result in hyperlipidemia, hypercholesterolemia, and elevated insulin resistance, and circulatory low-density lipoprotein cholesterol and total triglyceride levels. Hormonal replacement therapy, the primary treatment for hypothyroidism, partially restores the thyroid function and tappers down the disease symptoms. However, the therapy is associated a plethora of side effects, thus alternative therapies are warranted.
The effect of exercise on thyroid function and metabolism among patients with hypothyroidism is still equivocal. The soleus pushup exercise, a localized exercise that stimulates mainly oxidative metabolism, has been shown to have promising, favorable changes in systemic metabolism. Therefore, the current study compares metabolic and hormonal responses to soleus pushup exercise in patients with hypothyroidism versus healthy controls.
Patients diagnosed with hypothyroidism are recruited to participate in the study. Cardiovascular and circulatory, metabolic, and hormonal measures are determined from blood samples obtained from the patients. Age- and gender-matched healthy individuals are recruited to serve as controls.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Irbid Governorate
-
Irbid, Irbid Governorate, Jordan, 22110
- Rehabilitation Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Individuals aged 18-80,
- Patients diagnosed with hypothyroidism
- Patients diagnosed with hyperthyroidism
- Patients diagnosed with hypertension
- Patients diagnosed with diabetes mellitus
- Prediabetics
- Individuals who usually avoid regular physical/muscular activities involving lower limbs
- Age/gender matched apparently healthy individuals
Exclusion Criteria:
- Patients diagnosed with orthopedic diseases
- Patients diagnosed with cardiovascular diseases (other than hypertension)
- Patients diagnosed with renal dysfunction
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hypothyroid patients
|
The participants are given the soleus push-up exercise
|
|
Experimental: Health controls
|
The participants are given the soleus push-up exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total cholesterol
Time Frame: 3 hours
|
Total cholesterol will be measured in blood and reported in mg/dL.
|
3 hours
|
|
Triglycerides
Time Frame: 3 hours
|
Triglycerides will be measured in blood and reported in mg/dL.
|
3 hours
|
|
HDL-C
Time Frame: 3 hours
|
High-density lipoprotein cholesterol will be measured in blood and reported in mg/dL.
|
3 hours
|
|
LDL-C
Time Frame: 3 hours
|
Low-density lipoprotein cholesterol will be calculated using the lipid profile and reported in mg/dL.
|
3 hours
|
|
VLDL-C
Time Frame: 3 hours
|
Very-low-density lipoprotein cholesterol will be calculated from triglycerides and reported in mg/dL.
|
3 hours
|
|
Non-HDL cholesterol
Time Frame: 3 hours
|
Non-HDL cholesterol will be calculated as total cholesterol minus HDL-C and reported in mg/dL.
|
3 hours
|
|
Apolipoprotein A-I
Time Frame: 3 hours
|
Apolipoprotein A-I will be measured in blood and reported in mg/dL.
|
3 hours
|
|
Apolipoprotein B
Time Frame: 3 hours
|
Apolipoprotein B will be measured in blood and reported in mg/dL.
|
3 hours
|
|
Lipoprotein(a)
Time Frame: 3 hours
|
Lipoprotein(a) will be measured in blood and reported in mg/dL or nmol/L, depending on the laboratory assay.
|
3 hours
|
|
Fasting blood glucose
Time Frame: 3 hours
|
Fasting blood glucose will be measured in blood and reported in mg/dL.
|
3 hours
|
|
Random blood glucose
Time Frame: 3 hours
|
Random blood glucose will be measured in blood and reported in mg/dL.
|
3 hours
|
|
HbA1c
Time Frame: 3 hours
|
Glycated hemoglobin will be measured in blood and reported as a percentage.
|
3 hours
|
|
Insulin
Time Frame: 3 hours
|
Insulin will be measured in blood and reported in µIU/mL or mIU/L, depending on the laboratory assay.
|
3 hours
|
|
Glucagon
Time Frame: 3 hours
|
Glucagon will be measured in blood and reported in pg/mL.
|
3 hours
|
|
Catecholamines
Time Frame: 3 hours
|
Catecholamines will be measured in blood and reported in pg/mL.
|
3 hours
|
|
Thyroid-stimulating hormone
Time Frame: 3 hours
|
Thyroid-stimulating hormone will be measured in blood and reported in mIU/L or µIU/mL, depending on the laboratory assay.
|
3 hours
|
|
Triiodothyronine
Time Frame: 3 hours
|
Triiodothyronine will be measured in blood and reported in ng/dL.
|
3 hours
|
|
Thyroxine
Time Frame: 3 hours
|
Thyroxine will be measured in blood and reported in µg/dL.
|
3 hours
|
|
Brain-derived neurotrophic factor
Time Frame: 3 hours
|
Brain-derived neurotrophic factor will be measured in blood and reported in pg/mL or ng/mL, depending on the laboratory assay.
|
3 hours
|
|
Leptin
Time Frame: 3 hours
|
Leptin will be measured in blood and reported in ng/mL.
|
3 hours
|
|
Adiponectin
Time Frame: 3 hours
|
Adiponectin will be measured in blood and reported in µg/mL.
|
3 hours
|
|
Glucagon-like peptide
Time Frame: 3 hours
|
Glucagon-like peptide will be measured in blood and reported in pmol/L or pg/mL, depending on the laboratory assay.
|
3 hours
|
|
Heart rate
Time Frame: 3 hours
|
Heart rate will be measured using the standard auscultatory method and reported in beats per minute.
|
3 hours
|
|
Systolic blood pressure
Time Frame: 3 hours
|
Systolic blood pressure will be measured using the standard auscultatory method and reported in mmHg.
|
3 hours
|
|
Diastolic blood pressure
Time Frame: 3 hours
|
Diastolic blood pressure will be measured using the standard auscultatory method and reported in mmHg.
|
3 hours
|
|
Pulse pressure
Time Frame: 3 hours
|
Pulse pressure will be calculated as systolic blood pressure minus diastolic blood pressure and reported in mmHg.
|
3 hours
|
|
Rate-pressure product
Time Frame: 3 hours
|
Rate-pressure product will be calculated as heart rate multiplied by systolic blood pressure and reported in bpm × mmHg.
|
3 hours
|
|
Mean arterial pressure
Time Frame: 3 hours
|
Mean arterial pressure will be calculated as diastolic blood pressure plus one-third of pulse pressure and reported in mmHg.
|
3 hours
|
Collaborators and Investigators
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- JUST121212
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.
Clinical Trials on Hypertension
-
Josip Juraj Strossmayer University of OsijekOsijek University HospitalRecruitingEndothelial Dysfunction | Primary Hypertension | Pediatric HypertensionCroatia
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
University of Alabama at BirminghamTroy UniversityCompletedHypertension | Hypertension, Resistant to Conventional Therapy | Uncontrolled Hypertension | Hypertension, White CoatUnited States
-
Franz Rischard, DOAcceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway...Not yet recruitingPulmonary Hypertension | Pulmonary Arterial Hypertension (PAH)United States
-
Abant Izzet Baysal UniversityNot yet recruitingPRIMARY HYPERTENSIONTurkey (Türkiye)
-
SingHealth PolyclinicsNanyang PolytechnicEnrolling by invitationHypertension,EssentialSingapore
-
Hacettepe UniversityBozok UniversityCompletedHypertension | Arterial Hypertension | Systemic HypertensionTurkey (Türkiye)
-
BackBeat Medical IncNot yet recruitingHypertension, Systolic | Hypertension (HTN) | Heart Failure With Preserved Ejection Fraction (HFpEFGeorgia
-
Xuanwu Hospital, BeijingNot yet recruiting
-
Shenzhen Salubris Pharmaceuticals Co., Ltd.Not yet recruiting
Clinical Trials on Soleus pushup exercise
-
Riphah International UniversityCompleted
-
Nora Hussein KamalNot yet recruiting
-
University of SharjahNot yet recruiting
-
Riphah International UniversityCompleted
-
Victor H. DuenasMedical University of South Carolina; Eunice Kennedy Shriver National Institute...Completed
-
Superior UniversityActive, not recruitingConvergence InsufficiencyPakistan
-
Riphah International UniversityNot yet recruitingDiabetic Peripheral Neuropathy Type 2Pakistan
-
Riphah International UniversityRecruiting
-
Cairo UniversityNot yet recruiting
-
Cairo UniversityProf.Dr. Emad Samuel Boles Saweeres; Prof.Dr Nadia Abdelazim fayaz; Mr.Mohamed...CompletedAchilles TendinopathyEgypt