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Exercise and Intranasal Insulin in Type 2 Diabetes

2026年6月26日 更新者：Steven K Malin, PhD、Rutgers, The State University of New Jersey

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

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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

This goal of this study is to find out if exercise plus an insulin nose spray works better than exercise alone for brain blood flow in older adults with Type 2 Diabetes. This study will also look at how the brain uses insulin and thinking skills. Individuals will be randomized to one of two groups. One group will exercise and use an insulin nose spray. The other group will exercise and use a saline (placebo) nose spray. Exercise training will be supervised and consist of walking or light jogging 3 times per week for 16 weeks. Brain imaging, cognition, and blood tests will be conducted before and after the intervention. Other measures include fitness tests and body composition scans.

研究の種類

介入

入学 (推定)

60

段階

  • フェーズ2
  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • アメリカ
    • New Jersey
      • New Brunswick、New Jersey、アメリカ、08901
        • 募集
        • Rutgers University Loree Gymnasium
        • コンタクト：
      • New Brunswick、New Jersey、アメリカ、08901
        • 募集
        • Institute for Food, Nutrition, and Health
        • コンタクト：
      • New Brunswick、New Jersey、アメリカ、08091
        • 募集
        • Robert Wood Johnson University Hospital Clinical Research Center
        • コンタクト：
      • Piscataway、New Jersey、アメリカ、08854
        • 募集
        • Center for Advanced Human Brain Imaging Research
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • A diagnosis of dementia
  • Neurologic disease (e.g. Parkinson's, autonomic neuropathy, etc.)
  • 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)
  • Individuals who are smokers or who have quit smoking (<2 years)
  • Hypertriglyceridemia (400 mg/dl) and hypercholesterolemic (>260 mg/dl) subjects
  • Uncontrolled Hypertensive (>160/100 mmHg)
  • 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
  • Pregnant (as evidenced by positive pregnancy test) or nursing women
  • Participants with contraindications to participation in an exercise training program
  • 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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
プラセボコンパレーター：HiEx with Intranasal Placebo
薬：Intranasal Placebo
Saline will be administered twice daily (20 seconds in each nostril) using the Kurve Technology intranasal insulin device.
行動：High Intensity Exercise
High intensity exercise will consist of 16 weeks of walking at ~85% of each participant's predetermined VO2max and monitored via heart rate. Supervised exercised will occur on a treadmill 3d/wk. The duration of each exercise session will be adjusted based on fitness level so that ~300 kcal will be expended per training session during weeks 1-2, 350 kcal per training session during weeks 3-4, and 400 kcal per training session during weeks 5-16. This usually equals ~60 minutes per session but can vary from person to person. Each session will start with a 5-minute warm-up and end with a 5-minute cool down. During each exercise session, individuals will wear a heart rate monitor rating of perceived exertion will be recorded.
アクティブコンパレータ：HiEx with Intranasal Insulin
行動：High Intensity Exercise
High intensity exercise will consist of 16 weeks of walking at ~85% of each participant's predetermined VO2max and monitored via heart rate. Supervised exercised will occur on a treadmill 3d/wk. The duration of each exercise session will be adjusted based on fitness level so that ~300 kcal will be expended per training session during weeks 1-2, 350 kcal per training session during weeks 3-4, and 400 kcal per training session during weeks 5-16. This usually equals ~60 minutes per session but can vary from person to person. Each session will start with a 5-minute warm-up and end with a 5-minute cool down. During each exercise session, individuals will wear a heart rate monitor rating of perceived exertion will be recorded.
薬：Intranasal Insulin
Dosage will be 20 IU of INI twice per day (40 IU in total/day). The study will use the Kurve Technology intranasal device, which delivers a 20 second stream of insulin through a nose piece into a nostril, after which the device switches off. The process will then be repeated in the other nostril.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Cerebrovascular Insulin Sensitivity
時間枠：Change from baseline to the end of the intervention at 16 weeks

People will undergo a motion corrected diffusion weighted gradient-and spin echo pseudo-Continuous Arterial Spin Labeling (pCASL) sequence with 5 post labelling delays. This provides 3.5 mm3 resolution for whole brain coverage for CBF. CBF will be determined via the hippocampus.

Participants will then be administrated INI at a dose of 40 IU of human insulin (0.4 ml, Humulin, Eli Lilly & Co., Indianapolis, IN). Single puffs of 0.1ml will occur 4 times (twice each nostril) over 2 minutes via the VianaseTM electronic atomizers (Kurve Technology Inc., Lynnwood, WA). After 30 minutes, scanning will be repeated to determine CBF changes to indicate brain insulin sensitivity. Brain insulin sensitivity will be defined as the change from fasting to INI (e.g. CBFINI - CBFfast).
Change from baseline to the end of the intervention at 16 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Blood Brain Barrier Integrity
時間枠：Change from baseline to the end of the intervention at 16 weeks

People will undergo a motion corrected diffusion weighted gradient-and spin echo pseudo-Continuous Arterial Spin Labeling (pCASL) sequence with 5 post labelling delays. This provides 3.5 mm3 resolution for whole brain coverage for BBB water exchange (Kw). Kw will serve as primary index of BBB integrity.

Participants will then be administrated INI at a dose of 40 IU of human insulin (0.4 ml, Humulin, Eli Lilly & Co., Indianapolis, IN). Single puffs of 0.1ml will occur 4 times (twice each nostril) over 2 minutes via the VianaseTM electronic atomizers (Kurve Technology Inc., Lynnwood, WA). After 30 minutes, scanning will be repeated to determine BBB changes from fasting to INI (e.g. KwINI - Kwfast).
Change from baseline to the end of the intervention at 16 weeks
Insulin Signaling Proteins
時間枠：Change from baseline to the end of the intervention at 16 weeks

Insulin signaling proteins pIRS-1Ser636 and pAktSer473, derived from neuronal extracellular vesicles (nEVs) will be measured before and 30 minutes after intranasal insulin (e.g. nEVsINI - nEVsfast).

nEVs will be isolated from plasma samples through a 2-step method: 1) isolating total plasma nEVs via Size Exclusion Chromatography (SEC) and selective immunocapture targeting three neuronal-specific epitopes on intact EVs (L1CAM, NLGN3, and GAP43). Isolated nEVs concentration and size distribution will be assessed by nanoparticle tracking analysis (NTA). nEV concentration will be used to normalize protein biomarker values to account for differential recovery.
Change from baseline to the end of the intervention at 16 weeks
Augmentation Index
時間枠：Change from baseline to the end of the intervention at 16 weeks
Brachial artery augmentation index (AIx75) will be tested in the semi-supine position using the SphygmoCor device to depict arterial stiffness before and after INI (e.g. AIx75INI - AIx75fast).
Change from baseline to the end of the intervention at 16 weeks
Peripheral Insulin Sensitivity
時間枠：Change from baseline to the end of the intervention at 16 weeks
A 120 minute 75g OGTT will be used to depict insulin sensitivity.
Change from baseline to the end of the intervention at 16 weeks
Cognitive Function
時間枠：Change from baseline to the end of the intervention at 16 weeks
Cognitive function will be assessed via the NIH toolbox. The NIH toolbox is an iPad application that consists of cognitive, emotional, motor, and sensory function assessments. Specific measurements will include: Flanker Inhibitory Control and Attention Test, List Sorting Working Memory Test, Pattern Comparison Processing Speed Test, and Picture Sequence Memory Test.
Change from baseline to the end of the intervention at 16 weeks
Pulse Wave Velocity
時間枠：Change from baseline to the end of the intervention at 16 weeks
Pulse Wave Velocity (PWV) will be tested in the semi-supine position using the SphygmoCor device to depict arterial stiffness before and after INI (i.e. PWV-INI - PWV-fast).
Change from baseline to the end of the intervention at 16 weeks
Insulin Secretion
時間枠：Change from baseline to the end of the intervention at 16 weeks
A 120 minute 75g OGTT will be used to depict insulin secretion. Using the oral c-peptide minimal model (OMM), an estimate of 3 insulin secretion patterns will be be obtained: 1) one that is proportional to glucose rate change (i.e. early phase); 2) another proportional to plasma glucose above a threshold after a delay (i.e. late phase); and 3) total responsivity index, (total phase).
Change from baseline to the end of the intervention at 16 weeks

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Rutgers, The State University of New Jersey

協力者

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

捜査官

  • 主任研究者：Steven K Malin, PhD、Rutgers University - New Brunswick

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年8月3日

一次修了 (推定)

2029年5月18日

研究の完了 (推定)

2029年5月31日

試験登録日

最初に提出

2026年6月22日

QC基準を満たした最初の提出物

2026年6月26日

最初の投稿 (実際)

2026年6月30日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月30日

QC基準を満たした最後の更新が送信されました

2026年6月26日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • Pro2026000751
  • 1R01DK147509-01 (米国 NIH グラント/契約)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

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