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NCT07675499Toboroz2/3. fázis

Exercise and Intranasal Insulin in Type 2 Diabetes

Effects of Intranasal Insulin Plus Exercise Training on Brain Blood Flow, Neuronal Insulin Signaling, and Cognition in Adults With Type 2 Diabetes

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. jún. 30.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

About 6.5 million adults in the United States who are 65 or older have dementia. While the exact cause of dementia is not known, it may be due to changes in the brain. Further, risk may be higher when the brain does not respond to insulin. Indeed, brain insulin resistance has emerged as a pathologic factor affecting memory, executive function as well as systemic glucose control. Regular aerobic exercise may help reduce the risk of dementia by increased blood flow to the brain and help the brain respond better to insulin. In addition, giving insulin through a nose spray (called intranasal insulin) may also help with thinking and memory. However, it is unknown if using both exercise and intranasal insulin is best for the brain.

Állapot (regiszter)
Toboroz
Fázis (regiszter)
2/3. fázis
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
60 (tervezett)
Első benyújtás
2026. jún. 22.
Kezdés
2026. aug. 3.
Elsődleges befejezés
2029. máj. 18.
Fő szponzor
Rutgers, The State University of New Jersey
NCT-szám
NCT07675499

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó · 2/3. fázis
  • Tervezett résztvevők: 60
  • 2026. aug. 3. és az elsődleges befejezés (2029. máj. 18.) között
  • 4 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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Más betegség

  • A diagnosis of dementia
  • Neurologic disease (e.g. Parkinson's, autonomic neuropathy, etc.)
  • Participants with a history of significant metabolic, cardiac, cerebrovascular, hematological, pulmonary, gastrointestinal, liver, renal, or endocrine disease or cancer that in the investigator's opinion would interfere with or alter the outcome measures, or impact subject safety
  • Major psychiatric disorders (e.g. psychosis, bipolar disorder, major depression, alcohol/substance abuse)
  • History of head trauma or loss of consciousness in last 5 years.
  • Known contraindications for MR imaging:
    • History of head trauma or neurosurgery, or neurological disorder (other than headaches or peripheral nerve disease) as these may impact neuroimaging results.
    • Ferrous material implanted in or on the body, including flakes or filings, surgical clips, bullets, or electrical devices such as a pacemaker, or nonremovable ferrous jewelry (fillings in teeth and permanent retainers are permitted).
    • Fillings and permanent retainers do not provide a safety risk and are not general exclusions. However, upper retainers may cause artifacts in ventral frontal regions and therefore may be an exclusion for some studies.
    • Individuals with surgical pins or plates above the neck are excluded. Surgical pins or plates below the neck are exclusions, except when the material is fixed to bone, and considered acceptable by the Reference Manual for Magnetic Resonance Safety. Implants and Devices, 2020 Edition. Almost all recent orthopedic implants are made of materials that are not ferromagnetic and therefore are safe for scanning, and even though some screws are still made of ferromagnetic materials these are firmly screwed into bone. In cases where the material is unknown or deemed unsafe for scanning by the Reference Manual for Magnetic Resonance Safety. Implants and Devices the participant will be excluded.
    • History of eye injury involving metallic materials, shavings in eyes, or welding without a face mask
    • Lead/iron tattoos
    • Claustrophobia (history of significant anxiety in closed places).
    • Back problem that would prevent the subject from laying still comfortably for up to 90 minutes.
    • Deafness

Laborértékek

  • Hypertriglyceridemia (400 mg/dl) and hypercholesterolemic (>260 mg/dl) subjects

Életkor

  • Individuals who are smokers or who have quit smoking (<2 years)

Egyéb

  • Intolerance to insulin
  • Morbidly obese patients (BMI >40 kg/m2) and lean patients (BMI <25 kg/m2)
  • >2 kg weight change in past 6 months
  • Participants who have been recently active (>90 min of moderate/high intensity exercise)
  • Uncontrolled Hypertensive (>160/100 mmHg)
  • Pregnant (as evidenced by positive pregnancy test) or nursing women
  • Participants with contraindications to participation in an exercise training program

Kiket keres a vizsgálat

  • Male or female 55-80 years old
  • Type 2 diabetes diagnosis or confirmation HbA1c >6.5% and fasting glucose >126 mg/dl
  • Individuals prescribed metformin, GLP-1 agonists (oral/injectable), TZDs, DPP-IV inhibitors, Acarbose, SGLT-2 inhibitors >6 months.
  • MOCA ≥26
  • Body mass index (BMI) ≥25 and ≤40 kg/m2
  • Not diagnosed with Type 1 diabetes
  • Not currently engaged in <90 min/wk of exercise

Életkor a regiszterben: 55 év – 80 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (4)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
Rutgers University Loree GymnasiumNew BrunswickEgyesült ÁllamokToboroz
Institute for Food, Nutrition, and HealthNew BrunswickEgyesült ÁllamokToboroz
Robert Wood Johnson University Hospital Clinical Research CenterNew BrunswickEgyesült ÁllamokToboroz
Center for Advanced Human Brain Imaging ResearchPiscatawayEgyesült ÁllamokToboroz

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