Fasting in diabetes treatment (FIT) trial: study protocol for a randomised, controlled, assessor-blinded intervention trial on the effects of intermittent use of a fasting-mimicking diet in patients with type 2 diabetes.

Abstract:

BACKGROUND:Caloric restriction is an effective way to treat Type 2 diabetes (T2D). However, chronic and severe restriction of food intake is difficult to sustain and is known to promote slower metabolism. Intermittent and frequent fasting can exert similar metabolic effects, but may be even more challenging for most patients. A fasting-mimicking diet (FMD) is low in calories, sugars and proteins, but includes relatively high levels of plant based complex carbohydrates and healthy fats. The metabolic effects of such a diet mimic the benefits of water-only fasting. The effects of a FMD applied periodically in T2D patients are still unknown. The Fasting In diabetes Treatment (FIT) trial was designed to determine the effect of intermittent use (5 consecutive days a month during a year) of a FMD in T2D patients on metabolic parameters and T2D medication use compared to usual care. METHODS:One hundred T2D patients from general practices in the Netherlands with a BMI ≥ 27 kg/m2, treated with lifestyle advice only or lifestyle advice plus metformin, will be randomised to receive the FMD plus usual care or usual care only. Primary outcomes are HbA1c and T2D medication dosage. Secondary outcomes are anthropometrics, blood pressure, plasma lipid profiles, quality of life, treatment satisfaction, metabolomics, microbiome composition, MRI data including cardiac function, fat distribution and ectopic fat storage, cost-effectiveness, and feasibility in clinical practice. DISCUSSION:This study will establish whether monthly 5-day cycles of a FMD during a year improve metabolic parameters and/or reduce the need for medication in T2D. Furthermore, additional health benefits and the feasibility in clinical practice will be measured and a cost-effectiveness evaluation will be performed. TRIAL REGISTRATION:The trial was registered on ClinicalTrials.gov. Identifier: NCT03811587. Registered 21th of January, 2019; retrospectively registered.

journal_name

BMC Endocr Disord

journal_title

BMC endocrine disorders

authors

van den Burg EL,Schoonakker MP,van Peet PG,van den Akker-van Marle ME,Willems van Dijk K,Longo VD,Lamb HJ,Numans ME,Pijl H

doi

10.1186/s12902-020-00576-7

subject

Has Abstract

pub_date

2020-06-24 00:00:00

pages

94

issue

1

issn

1472-6823

pii

10.1186/s12902-020-00576-7

journal_volume

20

pub_type

杂志文章
  • Drug-related risk of severe hypoglycaemia in observational studies: a systematic review and meta-analysis.

    abstract:BACKGROUND:Diabetes mellitus (DM) leads to multiple complications, including severe hypoglycaemia events (SHEs). SHEs can impact a patient's quality of life and compliance and may directly result in additional costs to the health care system. The aim of this review was to evaluate the risk of severe hypoglycaemia in pa...

    journal_title:BMC endocrine disorders

    pub_type: 杂志文章,meta分析,评审

    doi:10.1186/s12902-015-0052-z

    authors: Czech M,Rdzanek E,Pawęska J,Adamowicz-Sidor O,Niewada M,Jakubczyk M

    更新日期:2015-10-12 00:00:00

  • Medication utilization patterns among type 2 diabetes patients initiating Exenatide BID or insulin glargine: a retrospective database study.

    abstract:BACKGROUND:Type 2 diabetes is a common and costly illness, associated with significant morbidity and mortality. Despite this, there is relatively little information on the 'real-world' medication utilization patterns for patients with type 2 diabetes initiating exenatide BID or glargine. The objective of this study was...

    journal_title:BMC endocrine disorders

    pub_type: 杂志文章

    doi:10.1186/1472-6823-13-20

    authors: Pawaskar M,Bonafede M,Johnson B,Fowler R,Lenhart G,Hoogwerf B

    更新日期:2013-06-22 00:00:00

  • Establishing a diagnostic scale of subacute thyroiditis without radioisotope scanning.

    abstract:BACKGROUND:Radioisotope scanning is important to diagnose subacute thyroiditis (SAT), but it's not always available. So we aim to establish a diagnostic scale for SAT without radioisotope scanning. METHODS:The suspected SAT patients hospitalized in Yuebei people's Hospital from January 2012 to December 2016 were selec...

    journal_title:BMC endocrine disorders

    pub_type: 杂志文章

    doi:10.1186/s12902-020-00554-z

    authors: Xiong Z,Luo C,Wang L,Xiong B,Wu J

    更新日期:2020-05-27 00:00:00

  • Factors associated with initiation of antihyperglycaemic medication in UK patients with newly diagnosed type 2 diabetes.

    abstract:AIM:To assess the factors associated with antihyperglycaemic medication initiation in UK patients with newly diagnosed type 2 diabetes. METHODS:In a retrospective cohort study, patients with newly diagnosed type 2 diabetes were identified during the index period of 2003-2005. Eligible patients were ≥ 30 years old at t...

    journal_title:BMC endocrine disorders

    pub_type: 杂志文章

    doi:10.1186/1472-6823-12-1

    authors: Sinclair AJ,Alexander CM,Davies MJ,Zhao C,Mavros P

    更新日期:2012-03-07 00:00:00

  • Reducing major lower extremity amputations after the introduction of a multidisciplinary team in patient with diabetes foot ulcer.

    abstract:BACKGROUND:Diabetic foot ulceration is receiving more attention because of its high amputation and mortality rate. It is essential to establish the frequency of amputations in people with diabetes after any change to the management of diabetic foot care. The present study aim to compare the frequency of lower-extremity...

    journal_title:BMC endocrine disorders

    pub_type: 杂志文章

    doi:10.1186/s12902-016-0111-0

    authors: Wang C,Mai L,Yang C,Liu D,Sun K,Song W,Luo B,Li Y,Xu M,Zhang S,Li F,Ren M,Yan L

    更新日期:2016-07-07 00:00:00

  • Anti-inflammatory effect of rosiglitazone is not reflected in expression of NFkappaB-related genes in peripheral blood mononuclear cells of patients with type 2 diabetes mellitus.

    abstract:BACKGROUND:Rosiglitazone not only improves insulin-sensitivity, but also exerts anti-inflammatory effects. We have now examined in type 2 diabetic patients if these effects are reflected by changes in mRNA expression in peripheral blood mononuclear cells (PBMCs) to see if these cells can be used to study these anti-inf...

    journal_title:BMC endocrine disorders

    pub_type: 杂志文章

    doi:10.1186/1472-6823-9-8

    authors: Bragt MC,Plat J,Mensink M,Schrauwen P,Mensink RP

    更新日期:2009-02-25 00:00:00

  • Screening for vitamin D deficiency in a tropical area: results of a sun exposure questionnaire.

    abstract:BACKGROUND:Vitamin D deficiency is pandemic while resources available to measure 25-hydroxyvitamin D (25OHD) are limited. The present study aimed to verify whether sun exposure measured by a structured questionnaire could predict serum 25OHD concentrations in healthy Caucasian individuals living in a tropical area. ME...

    journal_title:BMC endocrine disorders

    pub_type: 杂志文章

    doi:10.1186/s12902-018-0272-0

    authors: Bittar FB,Castro CHM,Szejnfeld VL

    更新日期:2018-07-03 00:00:00

  • Cardiac valvular abnormalities associated with use and cumulative exposure of cabergoline for hyperprolactinemia: the CATCH study.

    abstract:BACKGROUND:Whether lower dose cabergoline therapy for hyperprolactinemia increases risk of valvular dysfunction remains controversial. We examined valvular abnormalities among asymptomatic adults with hyperprolactinemia treated with dopamine agonists. METHODS:This cross-sectional study was conducted among adults recei...

    journal_title:BMC endocrine disorders

    pub_type: 杂志文章

    doi:10.1186/s12902-020-0507-8

    authors: Budayr A,Tan TC,Lo JC,Zaroff JG,Tabada GH,Yang J,Go AS

    更新日期:2020-02-19 00:00:00

  • Salivary cortisol differs with age and sex and shows inverse associations with WHR in Swedish women: a cross-sectional study.

    abstract:BACKGROUND:Most studies on cortisol have focused on smaller, selected samples. We therefore aimed to sex-specifically study the diurnal cortisol pattern and explore its association with abdominal obesity in a large unselected population. METHODS:In 2001-2004, 1811 men and women (30-75 years) were randomly selected fro...

    journal_title:BMC endocrine disorders

    pub_type: 杂志文章

    doi:10.1186/1472-6823-9-16

    authors: Larsson CA,Gullberg B,Råstam L,Lindblad U

    更新日期:2009-06-21 00:00:00

  • Insulin resistance as estimated by the homeostatic method at diagnosis of gestational diabetes: estimation of disease severity and therapeutic needs in a population-based study.

    abstract:BACKGROUND:Chronic insulin resistance, exacerbated in the course of pregnancy, is an important pathophysiologic mechanism of gestational diabetes mellitus (GDM). We hypothesise that the degree of insulin resistance, assessed at diagnosis of GDM, is a parameter of its pathophysiologic heterogeneity and/or severity. Thus...

    journal_title:BMC endocrine disorders

    pub_type: 杂志文章

    doi:10.1186/1472-6823-13-21

    authors: Sokup A,Ruszkowska-Ciastek B,Góralczyk K,Walentowicz M,Szymański M,Rość D

    更新日期:2013-07-02 00:00:00

  • Cost effectiveness and value of information analyses of islet cell transplantation in the management of 'unstable' type 1 diabetes mellitus.

    abstract:BACKGROUND:Islet cell transplantation is a method to stabilize type 1 diabetes patients with hypoglycemia unawareness and unstable blood glucose levels by reducing insulin dependency and protecting against severe hypoglycemia through restoring endogenous insulin secretion. This study analyses the current cost-effective...

    journal_title:BMC endocrine disorders

    pub_type: 杂志文章

    doi:10.1186/s12902-016-0097-7

    authors: Wallner K,Shapiro AM,Senior PA,McCabe C

    更新日期:2016-04-09 00:00:00

  • A novel loss-of-function mutation of GATA3 (p.R299Q) in a Japanese family with Hypoparathyroidism, Deafness, and Renal Dysplasia (HDR) syndrome.

    abstract:BACKGROUND:Hypoparathyroidism, deafness, and renal dysplasia (HDR) syndrome is a rare autosomal dominant disorder caused by mutations in the zinc finger transcription factor gene, GATA3. GATA3 has 2 zinc finger domains, which play an important role in the increase in target gene transcription activity. CASE PRESENTATI...

    journal_title:BMC endocrine disorders

    pub_type: 杂志文章

    doi:10.1186/s12902-015-0065-7

    authors: Okawa T,Yoshida M,Usui T,Kudou T,Iwasaki Y,Fukuoka K,Takahashi N,Uehara Y,Oiso Y

    更新日期:2015-10-30 00:00:00

  • Case report of a cystic parathyroidal adenoma with rapid growth induced by cinacalcet.

    abstract:BACKGROUND:Primary hyperparathyroidism is a rare condition of disease which can seldomly present as giant retrotrhyroideal cysts, complicating the localization of the adenoma to resect. CASE PRESENTATION:A 56-year old female presented with hypercalcaemia of 3.38 mmol/L (2.2-2.65 mmol/L) and a history of breast cancer....

    journal_title:BMC endocrine disorders

    pub_type: 杂志文章

    doi:10.1186/s12902-020-0532-7

    authors: Werner C,Lupp A,Mtuka-Pardon G,Kloos C,Wolf G,Aschenbach R,Biermann A,Freesmeyer M,Seifert P

    更新日期:2020-04-20 00:00:00

  • Insulin autoimmune syndrome induced by exogenous insulin injection: a four-case series.

    abstract:BACKGROUND:Insulin autoimmune syndrome (IAS) is a rare cause of hypoglycemia and is characterized by the presence of insulin autoantibodies. Patients with IAS usually complain of hypoglycemia without any previous insulin received. Glucocorticoids and immunosuppressants are used to treat IAS. CASE PRESENTATION:We repor...

    journal_title:BMC endocrine disorders

    pub_type: 杂志文章

    doi:10.1186/s12902-019-0482-0

    authors: Shen Y,Song X,Ren Y

    更新日期:2019-12-28 00:00:00

  • The association between improved quality diabetes indicators, health outcomes and costs: towards constructing a "business case" for quality of diabetes care--a time series study.

    abstract:BACKGROUND:In primary health care systems where member's turnover is relatively low, the question, whether investment in quality of care improvement can make a business case, or is cost effective, has not been fully answered.The objectives of this study were: (1) to investigate the relationship between improvement in s...

    journal_title:BMC endocrine disorders

    pub_type: 杂志文章

    doi:10.1186/1472-6823-14-92

    authors: Wilf-Miron R,Bolotin A,Gordon N,Porath A,Peled R

    更新日期:2014-12-01 00:00:00

  • Associations among IGF-1, IGF2, IGF-1R, IGF-2R, IGFBP-3, insulin genetic polymorphisms and central precocious puberty in girls.

    abstract:BACKGROUND:Insulin and insulin-like growth factor (IGF)-1 coupled with growth hormone helps control timing of sexual maturation. Mutations and variants in multiple genes are associated with development or reduced risk of central precocious puberty (CPP). METHODS:We assessed single nucleotide polymorphisms (SNPs) in th...

    journal_title:BMC endocrine disorders

    pub_type: 杂志文章

    doi:10.1186/s12902-018-0271-1

    authors: Chang HP,Yang SF,Wang SL,Su PH

    更新日期:2018-09-19 00:00:00

  • Non-invasive detection of microvascular changes in a paediatric and adolescent population with type 1 diabetes: a pilot cross-sectional study.

    abstract:BACKGROUND:The detection of microvascular damage in type 1 diabetes is difficult and traditional investigations do not detect changes until they are well established. The purpose of this study was to investigate the combined ability of nailfold capillaroscopy, laser Doppler flowmetry, retinal vessel analysis and 24-hr ...

    journal_title:BMC endocrine disorders

    pub_type: 杂志文章

    doi:10.1186/1472-6823-13-41

    authors: Hosking SP,Bhatia R,Crock PA,Wright I,Squance ML,Reeves G

    更新日期:2013-10-05 00:00:00

  • Severe hypoglycemia symptoms, antecedent behaviors, immediate consequences and association with glycemia medication usage: Secondary analysis of the ACCORD clinical trial data.

    abstract:BACKGROUND:Hypoglycemia is a common complication of diabetes treatment. This paper describes symptoms, predecessors, consequences and medications associated with the first episode of severe hypoglycemia among ACCORD participants with type 2 diabetes, and compares these between intensive (Int: goal A1C <6.0%) and standa...

    journal_title:BMC endocrine disorders

    pub_type: 杂志文章

    doi:10.1186/1472-6823-12-5

    authors: Bonds DE,Miller ME,Dudl J,Feinglos M,Ismail-Beigi F,Malozowski S,Seaquist E,Simmons DL,Sood A

    更新日期:2012-05-30 00:00:00

  • 1,25-dihydroxyvitamin D and PTHrP mediated malignant hypercalcemia in a seminoma.

    abstract:BACKGROUND:Seminomas have been rarely associated with malignant hypercalcemia. The responsible mechanism of hypercalcemia in this setting has been described to be secondary to 1,25-dihydroxyvitamin D secretion. The relationship with PTHrP has not been determined or studied.The aim of this study is to describe and discu...

    journal_title:BMC endocrine disorders

    pub_type: 杂志文章

    doi:10.1186/1472-6823-14-32

    authors: Rodríguez-Gutiérrez R,Zapata-Rivera MA,Quintanilla-Flores DL,Camara-Lemarroy CR,Lavalle-Gonzalez FJ,González-González JG,Villarreal-Pérez JZ

    更新日期:2014-04-10 00:00:00

  • Serum macroprolactin levels in pregnancy and association with thyroid autoimmunity.

    abstract:BACGROUND:To assess the contribution of macroprolactin to high serum prolactin levels and their association with thyroid status and thyroid autoimmunity during pregnancy. METHODS:138 pregnant women who suspected of having thyroid dysfunction were studied and divided into three groups according to the thyroid status; g...

    journal_title:BMC endocrine disorders

    pub_type: 杂志文章

    doi:10.1186/s12902-015-0025-2

    authors: Guclu M,Cander S,Kiyici S,Vatansever E,Hacihasanoğlu AB,Kisakol G

    更新日期:2015-06-20 00:00:00

  • Role of anti-Müllerian hormone and testosterone in follicular growth: a cross-sectional study.

    abstract:BACKGROUND:Anti-Müllerian hormone (AMH) is now considered the best serum biomarker of ovarian reserve, while basal sex hormones are classic markers used for assessing ovarian reserve. The interaction between AMH and sex hormones are complicated and not sufficiently addressed. In this study, we took diminished ovarian r...

    journal_title:BMC endocrine disorders

    pub_type: 杂志文章

    doi:10.1186/s12902-020-00569-6

    authors: Lv PP,Jin M,Rao JP,Chen J,Wang LQ,Huang CC,Yang SQ,Yao QP,Feng L,Shen JM,Feng C

    更新日期:2020-07-08 00:00:00

  • Overtime trend of thyroid hormones and thyroid autoimmunity and ovarian reserve: a longitudinal population study with a 12-year follow up.

    abstract:BACKGROUND:Ovarian reserve, vital for reproductive function, can be adversely affected by thyroid diseases. Despite alternations of thyroid hormones with ageing, data on interactions between the overtime trend of thyroid functions and ovarian reserve status has rarely been reported. We aimed to examine the overtime tre...

    journal_title:BMC endocrine disorders

    pub_type: 杂志文章

    doi:10.1186/s12902-019-0370-7

    authors: Bahri S,Tehrani FR,Amouzgar A,Rahmati M,Tohidi M,Vasheghani M,Azizi F

    更新日期:2019-05-07 00:00:00

  • Case report of one month and 15 days old baby with type V hyperlipoproteinemia (HLP).

    abstract:BACKGROUND:Most of the patients with type 1 and V hyperlipoproteinemia (HLP) present with symptoms and signs of acute pancreatitis due to marked elevation of triglycerides, but this baby presented with a chest infection, which was later diagnosed as type V HLP on laboratory workup. CASE PRESENTATION:We report a case o...

    journal_title:BMC endocrine disorders

    pub_type: 杂志文章

    doi:10.1186/s12902-020-0502-0

    authors: Dildar S,Shamsi TS

    更新日期:2020-02-11 00:00:00

  • Role of 18F-fluorodeoxyglucose (FDG) and 18F-2-fluorodeoxy sorbitol (FDS) in autoimmune hypophysitis: a case report.

    abstract:BACKGROUND:Autoimmune hypophysitis is a rare disease characterized by the infiltration of lymphocytic cells into the pituitary gland. 18F-fluorodeoxyglucose (FDG) and 18F-2-fluorodeoxy sorbitol (FDS) positron emission tomography (PET) are well-established and emerging techniques, respectively, which may aid in the diag...

    journal_title:BMC endocrine disorders

    pub_type: 杂志文章

    doi:10.1186/s12902-020-00567-8

    authors: Kong Z,Wang Y,Ma W,Cheng X

    更新日期:2020-06-09 00:00:00

  • Evaluation of the thyroid characteristics of patients with growth hormone-secreting adenomas.

    abstract:BACKGROUND:Acromegaly is highly associated with thyroid disorders. However, the clinical characteristics of thyroid nodules in individuals with acromegaly who present with thyroid diseases have not been completely elucidated. METHODS:Overall, 134 consecutive participants with growth hormone (GH)-secreting adenoma (n =...

    journal_title:BMC endocrine disorders

    pub_type: 杂志文章

    doi:10.1186/s12902-019-0424-x

    authors: Xu D,Wu B,Li X,Cheng Y,Chen D,Fang Y,Du Q,Chen Z,Wang X

    更新日期:2019-09-02 00:00:00

  • Increased waist circumference is independently associated with hypothyroidism in Mexican Americans: replicative evidence from two large, population-based studies.

    abstract:BACKGROUND:Mexican Americans are at an increased risk of both thyroid dysfunction and metabolic syndrome (MS). Thus it is conceivable that some components of the MS may be associated with the risk of thyroid dysfunction in these individuals. Our objective was to investigate and replicate the potential association of MS...

    journal_title:BMC endocrine disorders

    pub_type: 杂志文章,多中心研究

    doi:10.1186/1472-6823-14-46

    authors: Mamtani M,Kulkarni H,Dyer TD,Almasy L,Mahaney MC,Duggirala R,Comuzzie AG,Samollow PB,Blangero J,Curran JE

    更新日期:2014-06-10 00:00:00

  • Plasma level of peroxiredoxin 3 in patients with polycystic ovarian syndrome.

    abstract:BACKGROUND:As a member of peroxiredoxin (PRX) family, PRX3 is predominantly located in mitochondria and plays an important role of free radical scavenging. Since a body of evidence demonstrated the involvement of PRX3 in insulin secretion, insulin sensitivity, and glucose metabolism, the present study was conducted to ...

    journal_title:BMC endocrine disorders

    pub_type: 杂志文章

    doi:10.1186/s12902-019-0358-3

    authors: Liu HL,Li TT,Yu AQ,Li J,Li X,Li L,Kaifu T

    更新日期:2019-03-14 00:00:00

  • Early limited nitrosamine exposures exacerbate high fat diet-mediated type 2 diabetes and neurodegeneration.

    abstract:BACKGROUND:Type 2 diabetes mellitus (T2DM) and several types of neurodegeneration, including Alzheimer's, are linked to insulin-resistance, and chronic high dietary fat intake causes T2DM with mild neurodegeneration. Intra-cerebral Streptozotocin, a nitrosamine-related compound, causes neurodegeneration, whereas periph...

    journal_title:BMC endocrine disorders

    pub_type: 杂志文章

    doi:10.1186/1472-6823-10-4

    authors: Tong M,Longato L,de la Monte SM

    更新日期:2010-03-19 00:00:00

  • Oxytocin and cardioprotection in diabetes and obesity.

    abstract::Oxytocin (OT) emerges as a drug for the treatment of diabetes and obesity. The entire OT system is synthesized in the rat and human heart. The direct myocardial infusion with OT into an ischemic or failing heart has the potential to elicit a variety of cardioprotective effects. OT treatment attenuates cardiomyocyte (C...

    journal_title:BMC endocrine disorders

    pub_type: 杂志文章,评审

    doi:10.1186/s12902-016-0110-1

    authors: Jankowski M,Broderick TL,Gutkowska J

    更新日期:2016-06-07 00:00:00

  • Family physician and endocrinologist coordination as the basis for diabetes care in clinical practice.

    abstract:BACKGROUND:To estimate the proportion of diabetic patients (DPts) with peripheral vascular disease treated at a primary health care site after an endocrinologist-based intervention, who meet ATP III and Steno targets of metabolic control, as well as to compare the outcome with the results of the patients treated by end...

    journal_title:BMC endocrine disorders

    pub_type: 杂志文章

    doi:10.1186/1472-6823-8-9

    authors: Duran A,Runkle I,Matía P,de Miguel MP,Garrido S,Cervera E,Fernandez MD,Torres P,Lillo T,Martin P,Cabrerizo L,de la Torre NG,Calle JR,Ibarra J,Charro AL,Calle-Pascual AL

    更新日期:2008-07-31 00:00:00