Hypothyroidism, Metabolism and Food Intake (Hypomafia)
Levothyroxine Substitution Therapy in Hypothyroid Patients - Impact on Appetite and Food Intake
This project has the following primary aims:
To measure changes in appetite and food intake in newly diagnosed hypothyroid patients during the first six months after starting levothyroxine (L-T4) substitution therapy
Secondary aims are:
To delineate the effect of L-T4 substitution therapy on thyroid status, body weight, body mass index (BMI), body composition, physical activity, glycaemic control, postprandial gut and pancreatic hormone responses, gastric and gall bladder emptying, resting energy expenditure (REE), quality of life (QOL) and cognitive function
調査の概要
詳細な説明
18 newly diagnosed hypothyroid female patients and 18 healthy controls age between 20 and 75 years will be recruited from the out-patients clinic in Herlev and Gentofte Hospital and the general practitioners before start of substitution therapy.
The study is devided in to three identical experimental days of approx. 6 hours. First experimental day placed before T4 treatment is initiated. Second day as soon as Thyroid Stimulating Hormone (TSH) is below 4 milli unit pr liter (mU/l). The Third experimental day after 6 months of T4 therapy.
For 5-7 days before each experimental day, the participants' physical activity energy expenditure (PAEE) will be monitored by an Actiheart® pedometer attached to the skin of the chest.
The last two days before each experimental day, the participants will follow a standardised diet following World Health Organization guidelines on energy requirements and nutrient composition according to gender, age and body weight Shortly after diagnosis patients will undergo a test panel at the first experimental day, where patients arrives fasting.
Visual analog score on satiety and thirst will be filled out continuously. REE will be measured by a CCM-express calorimeter,
- Dual Energy X-ray absorptiometry (DEXA)-scan
- Blood samples will be taken continuously during the experimental day. Gall bladder size will be examined at 6 times during the experimental day using ultra sound.
At the end of the day, patients´ satiety will be examined with an ad libitum meal.
Blood will be analysed for Gastric inhibitory polypeptide (GIP), Glucagon-like Peptide 1 (GLP-1), Glucagon-like Peptide 2 (GLP-2), glucagon, peptide tyrosine tyrosine (PYY), Gastrin, Cholesystokinin (CCK), Insulin, C-peptide, Blood sugar, Cholesterol, Free fatty acids and paracetamol.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Region Hovedstaden
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Copenhagen、Region Hovedstaden、デンマーク、2900
- Center for Diabetes Research, Herlev and Gentofte Hospitals
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- TSH > 10
- Female
Exclusion Criteria:
- Competing serious disease
- Male
- Not able to understand written and spoken danish
- Pregnancy
- Thyroidectomized patients
- Amiodarone treatment.
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
---|---|
Hypothyroid patients
Hypothyroid patients treated with Levothyroxine as part of normal treatment.
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Normal treatment with levothyroxine.
他の名前:
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Healthy volunteers
Matched on age and BMI.
18 Persons.
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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 |
---|---|---|
Changes in food intake at ad libitum meal
時間枠:6 months
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Changes in food intake at ad libitum meal measured at each experimental day
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6 months
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Satiety
時間枠:6 months
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Satiety measured on a visual analog score 13 times during each experimental day.
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6 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Changes in lean mass assessed through lean mass
時間枠:6 months
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Changes in lean mass assessed through lean mass with DEXA-scan
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6 months
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Changes in fat mass assessed through lean mass with DEXA-scan
時間枠:6 months
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Changes in lean mass assessed through lean mass with DEXA-scan
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6 months
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Changes in gall bladder emptying
時間枠:6 months
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Changes in gall bladder emptying evaluated with ultrasound 6 times each experimental day before and after meal.
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6 months
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Changes in resting energy expenditure
時間枠:6 months
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Changes in resting energy expenditure measured 3 times each experimental day using Indirect Calorimetry.
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6 months
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Changes in blood sugar response to standardized meal.
時間枠:6 Months
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changes in blood sugar response to standardized meal measured before and after meal at each experimental day.
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6 Months
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Changes in stomach emptying
時間枠:6 months
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Evaluated with continously measuring serum paracetamol after standardized meal containing 1,5 g paracetamol.
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6 months
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Changes in GIP hormones
時間枠:6 months
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Continously measuring of a range of hormones during each experimental day: GIP
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6 months
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Changes in GLP-1 hormones
時間枠:6 months
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Continously measuring of GLP-1 hormones during each experimental day
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6 months
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Changes in GLP-2 hormones
時間枠:6 Months
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Continuously measuring of GLP-2 hormones during each experimental day
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6 Months
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Changes in PYY hormones
時間枠:6 Months
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Continuously measuring of PYY hormones during each experimental day
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6 Months
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Changes in CCK hormones
時間枠:6 Months
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Continuously measuring of CCK hormones during each experimental day
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6 Months
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Changes in Gastrin hormones
時間枠:6 Months
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Continuously measuring of Gastrin during each experimental day
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6 Months
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Changes in Insulin hormones
時間枠:6 Months
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Continuously measuring of Insulin during each experimental day
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6 Months
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Changes in Glucagon
時間枠:6 Months
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Continuously measuring of Glucagon during each experimental day
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6 Months
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Changes in C-peptide
時間枠:6 Months
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Continuously measuring of C-peptide during each experimental day
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6 Months
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Changes in Free-Fatty acids
時間枠:6 Months
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Continuously measuring of Free Fatty acids during each experimental day
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6 Months
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Bjarke B Medici, MD、Department of Internal Medicine, Herlev and Gentofte hospitals.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- Herlev-Gentofte Hypomafia
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?
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